MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ENTOVIS SR-T; PACEMAKER

Model Number	365467
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
According to physician complaint the device reach eol in short period.
Additional Manufacturer Narrative
The pacemaker was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker was subjected to an electrical incoming inspection.During initial interrogation a warning message on the programmer was displayed indicating a potential battery depletion and an invalid memory content.The pacemakers memory content was analyzed confirming this observation.The ability of the device to deliver therapies was verified revealing that no anti-bradycardia therapy functionality was present.Therefore, the pacemaker was opened.The visual inspection of the inner assembly showed no anomalies.Subsequent thorough investigations of the electronic module revealed a damaged capacitor resulting in the clinical observation.In summary, a damaged capacitor was identified during analysis leading to the clinical observation.However, the manufacturing records document a normal device production.It is therefore assumed, that the damage occurred after the device shipment, however the date of occurrence was not determinable.

• Brand Name: ENTOVIS SR-T
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8897316
• Report Number: 1028232-2019-03510
• Device Sequence Number: 1561309
• Product Code: NVZ
• UDI-Device Identifier: 04035479109837
• UDI-Public: 04035479109837
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: 06/30/2013
• Device Model Number: 365467
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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