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PSW
BIOTRONIK SE & Co. KG · Model 1403.U · UDI-DI 04035479147143
OSR
Prescription
0
510(k) clearances
58,914
Adverse events (2 deaths)
15
Recalls
34
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-10 | St. Jude Medical, Cardiac Rhythm Management Division | Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchroniza |
| 2021-10-12 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | The processing of collected episode data may fail due to a software error. |
| 2021-04-06 | Medtronic 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 |
| 2020-01-30 | Medtronic 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. |
| 2020-01-30 | Medtronic 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. |
| 2019-10-03 | Medtronic 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 |
| 2019-10-03 | Medtronic 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 |
| 2019-10-03 | Medtronic 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 |
| 2019-01-17 | Medtronic 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 |
| 2019-01-17 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore pr |
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Get your free API keyRead the docsData 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.