MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 5 HF-T QP DF4 IS4 PROMRI; ICD

Model Number	429561
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this device could not be interrogated.The device was explanted.
Additional Manufacturer Narrative
Upon receipt, the icd was subjected to an electrical analysis, revealing that the device could not be interrogated, confirming the clinical observation.Therefore, the device was opened and the inner assembly was inspected.The visual inspection revealed a damaged high voltage capacitor and fluid deposits of the damaged capacitor were found on several electronic components.The measurement of the battery voltage showed a depleted battery.Therefore, the capacitor was sent to the manufacturer for further investigations.The analysis at the manufacturer confirmed the capacitor damage, which caused fluid leakage on the circuit board and therefore to the clinical observation.In conclusion, the clinical observation resulted from a damaged high voltage capacitor.There was no sign of any inconsistency during the manufacturing process which may be related to the observed damage.It is therefore assumed that the damage occurred after the device shipment, however, the date of occurrence was not determinable.

• Brand Name: RIVACOR 5 HF-T QP DF4 IS4 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: 11547449
• Report Number: 1028232-2021-01348
• Device Sequence Number: 3147784
• Product Code: NIK
• UDI-Device Identifier: 04035479156879
• UDI-Public: 04035479156879
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 04/30/2022
• Device Model Number: 429561
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2020
• 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