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

Model Number	394971
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Eri status has been found at the hospital, and it has been at eri since (b)(6) 2019.The last follow up was (b)(6) 2018 without problem.
Additional Manufacturer Narrative
Device explanted on (b)(6) 2019.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.The final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker was interrogated showing a warning message on the programmer indicating a potential elevated current consumption.Therefore, the memory content of the device was analyzed, confirming this observation.The eri battery status was triggered on (b)(6) 2019 as a result of the elevated current consumption draining the battery.The ability of the device to deliver therapies was verified revealing that no anti-bradycardia therapy functionality was present as a result of the battery depletion.During the further course of the analysis, the pacemaker was opened to inspect the inner assembly and to check the functionality of the electronic module.Visually no deficiencies were observed.The current consumption of the electrical module was directly measured and found to be elevated.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: ELUNA 8 SR-T PROMRI
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9199510
• Report Number: 1028232-2019-04531
• Device Sequence Number: 306117
• Product Code: NVZ
• UDI-Device Identifier: 04035479131951
• UDI-Public: 04035479131951
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/16/2019

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: 04/30/2017
• Device Model Number: 394971
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1