FDA Device Intelligence
Home › MICROPORT CRM SRL › CPR4BR accessory

CPR4BR accessory

MICROPORT CRM SRL · Model B10000 · UDI-DI 08031527017754

OSR Prescription
0
510(k) clearances
55,908
Adverse events (2 deaths)
15
Recalls
34
Facilities

Description

MicroPort CPR4BR accessory

Recalls

DateFirmReason
2022-03-10St. Jude Medical, Cardiac Rhythm Management DivisionDue to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchroniza
2021-10-12Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)The processing of collected episode data may fail due to a software error.
2021-04-06Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device tri
2020-01-30Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
2020-01-30Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
2019-10-03Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac de
2019-10-03Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac de
2019-10-03Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac de
2019-01-17Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices.
2019-01-17Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended R

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.