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

Model Number	359533
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as the returned device data.The manufacturing process for this device 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 thoroughly analyzed.In particular the returned pacemaker dump was analyzed revealing an elevated current consumption since (b)(6) 2021, triggering, by design, a warning message to alert the user.However, the elevated current consumption might be an indication that an electronic module component is damaged.The eri battery status was activated on (b)(6) 2021.However, based on the information available no definite root cause was determinable.It was reported that the pacemaker was explanted.Should additional relevant information or the device itself become available, the investigation will be updated.
Event or Problem Description
It was reported that there was a rapid decrease in battery via hm.Device was explanted.

• Brand Name: EVIA SR-T
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• MDR Report Key: 12442952
• Report Number: 1028232-2021-05030
• Device Sequence Number: 4739615
• Product Code: NVZ
• UDI-Device Identifier: 04035479101350
• UDI-Public: 04035479101350
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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: 11/30/2013
• Device Model Number: 359533
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 09/08/2021
• 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