MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ELUNA 8 SR-T PROMRI; PACEMAKER

Model Number	394971
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Device was eri at follow-up.The device remains implanted.
Additional Manufacturer Narrative
The device was 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 this particular device.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process, which might be related to the clinical observation.The returned device data were analyzed.The analysis revealed that the device activated the battery status eri as a result of an invalid memory content.However, the battery is definitely not depleted.In general, the pacemaker is equipped with the ability to detect and repair invalid memory content.In case of invalid memory content in an area related to specific device data, the pacemaker will -by design- activate the device status eri.This does not represent a device malfunction.It was not reported whether the device was reset.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.Based on the data available for analysis, the clinical observation resulted from an invalid memory content.The root cause for the invalid memory content was not determinable.However, it cannot be excluded that the presence of invasive external influences, such as strong electromagnetic fields, might have contributed to the observed behavior.

• Brand Name: ELUNA 8 SR-T PROMRI
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8595438
• Report Number: 1028232-2019-01905
• Device Sequence Number: 1981944
• Product Code: NVZ
• UDI-Device Identifier: 04035479131951
• UDI-Public: 04035479131951
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: 07/31/2018
• Device Model Number: 394971
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1