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 Convert Rhythm (1540)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	07/12/2021
Type of Reportable Event	Death
Event or Problem Description
27 days after implantation it was reported that the patient died after an electrical storm and unsuccessful reanimation.
Additional Manufacturer Narrative
The icd and fragments of the leads were returned for analysis.Upon receipt, the leads fragments were still connected to the icd header.The plexa lead was found cut 22 cm distal to the df4 connector pin and the sentus lead 28 cm distal to the is4 connector pin.The proximal fragments of both leads were received for analysis.The distal fragments including the leads tips were not returned.It is reasonable to assume that the leads were cut during the extraction procedure.The inspection revealed that the insulation of both leads was, apart from the present cuts, free of breaches.Analysis of the returned lead fragments did not reveal any irregularity that might have contributed to the reported clinical observations.The manufacturing processes for the leads were re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The icd was visually inspected.The inspection revealed signs of an electrical arc-over on the icd housing as well as on the icd antenna inside the header.This indicates shock delivery into an external short circuit between icd case and antenna.Subsequently, the icd was subjected to an electrical analysis.Thereby the device could not be interrogated, and the therapy functionality was not available.The icd was opened, and the inspection of the inner assembly revealed a damaged electronic module due to an external short circuit.In particular, the fuse separating the battery from the electronic module was blown.These damages led to the lack of interrogation and therapy functionality.The header of the icd was inspected in detail.The root cause of the external short circuit could be tracked down to a misaligned placement of the antenna due to an individual error during assembly of the device header of this particular icd.Despite multiple inspection steps, this misalignment was not identified during production.As a result of this event, processes have been reviewed and relevant staff has been retrained.In accordance to biotroniks post-market surveillance system this occurrence represents a very rare event.Based on the analysis, the root cause of the patients death was not determinable, as the icd could not be interrogated, and data were not available.It is unclear whether the damage of the icd occurred before or after the patient passed away.

• 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: 12294048
• Report Number: 1028232-2021-04442
• Device Sequence Number: 3817773
• 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: 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): 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 429561
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2021
• 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: Death
• Patient Sex: Unknown