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	10/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Device was explanted due to loss of capture.Should additional information become available, this report will be updated.
Additional Manufacturer Narrative
The device was returned for analysis.Upon receipt, the pacemaker was interrogated and the memory content was analyzed.Intermittent loss of capture in the ventricle could be confirmed during inspection of iegm data.Furthermore, trend data show an unsteady bipolar ventricular lead impedance with measured values ranging between about 100ohm and 275ohm.The header of the device was analyzed.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.All dimensions of the header bores were within the range requested by the standard specifications.No deviations were observed which might have led to the reported clinical event.The quality documents accompanying the manufacturing process for this device were re-investigated and all production steps were performed accordingly.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.There was no indication of a device malfunction.An additional long-term pacing test was initiated.During the test, each pacing pulse was recorded.The evaluation of these pacing pulses documented regular device behavior.There was no intermittent or permanent loss of output.In conclusion, the device was fully functional during analysis.The pacemaker proved to be fully capable to deliver appropriate anti-bradycardia therapy.

• Brand Name: EPYRA 8 DR-T
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10864585
• Report Number: 1028232-2020-05032
• Device Sequence Number: 19483276
• Product Code: NVZ
• UDI-Device Identifier: 04035479131814
• UDI-Public: 04035479131814
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 394930
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR