MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 5 DR-T DF4 PROMRI; ICD

Model Number	429563
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.9 months, it was observed that the icd was not able to charge the capacitor and drained the battery by trying over and over.The icd was explanted.
Additional Manufacturer Narrative
The icd was returned for analysis.Prior to the analysis 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.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt the device was interrogated and the memory content was inspected.45 aborted automatic capacity reformations were recorded to the devices memory between (b)(6), 2020.The battery was still sufficiently charged and showed the mol1 battery status.The device data further showed that a re-initialization was performed on (b)(6), 2020, the day of device explantation.As a result, historical data were not available for analysis.Since re-initialization the icd is operating as expected.The capacitor reformation counter documented expected reformation intervals.The device was subjected to a functional inspection.First, the capacitor reformation functionality was tested by manually triggered reformation, showing an expected charging cycle with a charging time of 8.6 sec.Long-term storage of the icd did not show any anomalies, particularly the clinical observation was not reproducible.Next, the ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.In conclusion, analysis of the device data revealed frequently repeated automatic capacitor reformations between (b)(6), 2020.After re-initialization of the device on (b)(6), 2020 the icd was operating as expected.Despite dedicated analysis, no conclusion can be drawn regarding the root cause for this observation.As a re-initialization was performed during the explantation procedure, historical device data were not available for further analysis.Biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.

• Brand Name: RIVACOR 5 DR-T DF4 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 11188829
• Report Number: 1028232-2021-00313
• Device Sequence Number: 19390984
• Product Code: MRM
• UDI-Device Identifier: 04035479156893
• UDI-Public: 04035479156893
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 07/31/2021
• Device Model Number: 429563
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown