MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EPYRA 8 DR-T; PACEMAKER

Model Number	394930
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.66 months, a loss of capture on the ventricular channel was observed.The patient was hospitalized.Device remains implanted.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The pacemaker and the associated lead were not returned for analysis.The analysis is therefore based on the returned device data, as well as the inspection of the quality documents associated with the manufacture of these particular devices.The manufacturing process for pacemaker and lead was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.The returned device data were analyzed thoroughly.Iegms and ecgs were not available for analysis, but the ram data did not show any indication of a pacemaker malfunction.However, the data documented several loss of capture detections since november 2021.On (b)(6), 2022 ventricular capture control was deactivated automatically as a result of reaching the maximum amount of loss of capture detections within 24 hours.The root cause for the loss of capture detections could not be determined conclusively.Should additional relevant information or the device itself become available, the investigation will be updated.

• Brand Name: EPYRA 8 DR-T
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14783046
• Report Number: 1028232-2022-03213
• Device Sequence Number: 5812854
• Product Code: NVZ
• UDI-Device Identifier: 04035479131814
• UDI-Public: 04035479131814
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 394930
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown