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

Model Number	371994
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.73 months, a battery error message was reported during the follow-up for the planned exchange of the device.The pacemaker was explanted.
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the existing production documents and the returned device data.The manufacturing process of this device was reviewed.The production documents showed no anomalies.All manufacturing steps had been carried out correctly.A performed standard final electrical test documented proper device behavior.The provided device data were thoroughly analyzed.In particular, the battery voltage was checked regarding to the charge drawn from the battery based on the device data, and it turned out not to be as expected.Based on the available device data, it was not possible to determine the cause of the clinical observation.An examination of the pacemaker is thus necessary for a more detailed analysis.It was reported that the implant was explanted but is not available for analysis.If additional relevant information should become available, the incident will be updated accordingly.

• Brand Name: ENTOVIS SR-T PROMRI
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10010598
• Report Number: 1028232-2020-01887
• Device Sequence Number: 14033593
• Product Code: NVZ
• UDI-Device Identifier: 04035479115197
• UDI-Public: 04035479115197
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 04/30/2014
• Device Model Number: 371994
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 08/13/2020
• 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