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PK-83-B/2,5m
BIOTRONIK SE & Co. KG · Model 347485 · UDI-DI 04035479079581
DTE
Prescription
0
510(k) clearances
13,014
Adverse events (85 deaths)
5
Recalls
17
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-28 | Bio-Detek, Inc. | Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy. |
| 2018-06-06 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpe |
| 2015-03-17 | Medtronic Inc. Cardiac Rhythm Disease Management | Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connec |
| 2010-06-30 | Osypka Medical Inc | The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V b |
| 2010-06-30 | Osypka Medical Inc | The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V b |
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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.