Product Surveillance Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +36
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Medtronic Product Surveillance Registry
Overview
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
Primary outcome measures
- Safety and Effectiveness of Market Released products [Time frame: Every 6-12 months (Therapy-dependent)]
Eligibility criteria
Inclusion criteria
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has or is intended to receive or be treated with an eligible Medtronic product
- Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment
Exclusion criteria
- Patient who is, or will be, inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 134 centers
- Center not named — Birmingham
- Center not named — Huntsville
- Center not named — Chandler
- Center not named — Phoenix
- Center not named — Little Rock
- Center not named — Aliso Viejo
- Center not named — Chula Vista
- Center not named — Colton
- … and 126 more centers
Japan · 38 centers
Center list to be confirmed — check the primary protocol.
Germany · 26 centers
Center list to be confirmed — check the primary protocol.
France · 25 centers
Center list to be confirmed — check the primary protocol.
Italy · 18 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 17 centers
Center list to be confirmed — check the primary protocol.
Spain · 16 centers
Center list to be confirmed — check the primary protocol.
South Korea · 14 centers
Center list to be confirmed — check the primary protocol.
China · 13 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 12 centers
Center list to be confirmed — check the primary protocol.
Belgium · 10 centers
Center list to be confirmed — check the primary protocol.
India · 8 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 8 centers
Center list to be confirmed — check the primary protocol.
Canada · 6 centers
Center list to be confirmed — check the primary protocol.
Portugal · 5 centers
Center list to be confirmed — check the primary protocol.
Australia · 4 centers
Center list to be confirmed — check the primary protocol.
Colombia · 4 centers
Center list to be confirmed — check the primary protocol.
Denmark · 4 centers
Center list to be confirmed — check the primary protocol.
Israel · 4 centers
Center list to be confirmed — check the primary protocol.
Greece · 3 centers
Center list to be confirmed — check the primary protocol.
Norway · 3 centers
Center list to be confirmed — check the primary protocol.
Poland · 3 centers
Center list to be confirmed — check the primary protocol.
Sweden · 3 centers
Center list to be confirmed — check the primary protocol.
Austria · 2 centers
Center list to be confirmed — check the primary protocol.
Finland · 2 centers
Center list to be confirmed — check the primary protocol.
Puerto Rico · 2 centers
Center list to be confirmed — check the primary protocol.
Saudi Arabia · 2 centers
Center list to be confirmed — check the primary protocol.
Argentina · 1 center
Center list to be confirmed — check the primary protocol.
Brazil · 1 center
Center list to be confirmed — check the primary protocol.
Czechia · 1 center
Center list to be confirmed — check the primary protocol.
Hong Kong · 1 center
Center list to be confirmed — check the primary protocol.
Hungary · 1 center
Center list to be confirmed — check the primary protocol.
Ireland · 1 center
Center list to be confirmed — check the primary protocol.
Kuwait · 1 center
Center list to be confirmed — check the primary protocol.
Malaysia · 1 center
Center list to be confirmed — check the primary protocol.
Mexico · 1 center
Center list to be confirmed — check the primary protocol.
New Zealand · 1 center
Center list to be confirmed — check the primary protocol.
Panama · 1 center
Center list to be confirmed — check the primary protocol.
Serbia · 1 center
Center list to be confirmed — check the primary protocol.
Slovakia · 1 center
Center list to be confirmed — check the primary protocol.
Taiwan · 1 center
Center list to be confirmed — check the primary protocol.
Publications
- Wu V, Makary MS, Tarter W, Elsaadany A, Shrestha P. Real-World Safety and Performance of Nylon and PGLA Fibered Detachable Coils in Peripheral Embolization: A Prospective Multicenter Registry. J Vasc Interv Radiol. 2026 Jul 14:108959. doi: 10.1016/j.jvir.2026.108959. Online ahead of print. PMID 42448174
- Quyn A, Navarro A, Caldonazo T, Findlay JM, Doenst T, Anderson M, Gong X, Botman JMJ. Real-World Performance of the Veriset Hemostatic Patch: A Multicenter Study of Adjunctive Hemostasis. Med Devices (Auckl). 2026 May 29;19:595863. doi: 10.2147/MDER.S595863. eCollection 2026. PMID 42239929
- Goya M, Park SJ, Ando K, Holbrook R, Iskandar R, Jacobsen L, Mozingo JD, Joung B; SPARK Registry Investigators. Safety and efficacy of an intrinsic antitachycardia pacing algorithm in patients from Japan and South Korea: results from a cardiac device registry in the Asia Pacific region. J Med Econ. 2025 Dec;28(1):1307-1318. doi: 10.1080/13696998.2025.2543213. Epub 2025 Aug 13. PMID 40758483
- Patel D, Rao A, Friedman PA, Deshmukh AJ, Lande J, Murphy JA, Brown ML, Lexcen DR, Wilkoff BL. New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation. J Cardiovasc Electrophysiol. 2023 Feb;34(2):438-444. doi: 10.1111/jce.15790. Epub 2022 Dec 30. PMID 36579406
- Qin D, Filippaios A, Murphy J, Berg M, Lampert R, Schloss EJ, Noone M, Mela T. Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e011029. doi: 10.1161/CIRCEP.122.011029. Epub 2022 Aug 4. PMID 35925831
- Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4. PMID 32763431
- Singh JP, Cha YM, Lunati M, Chung ES, Li S, Smeets P, O'Donnell D. Real-world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence. J Cardiovasc Electrophysiol. 2020 Apr;31(4):825-833. doi: 10.1111/jce.14376. Epub 2020 Feb 28. PMID 32009263
- Stearns LM, Abd-Elsayed A, Perruchoud C, Spencer R, Hammond K, Stromberg K, Weaver T. Intrathecal Drug Delivery Systems for Cancer Pain: An Analysis of a Prospective, Multicenter Product Surveillance Registry. Anesth Analg. 2020 Feb;130(2):289-297. doi: 10.1213/ANE.0000000000004425. PMID 31567325
Identifiers
NCT: NCT01524276 · PSR