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

Model Number	429565
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	06/27/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died approx.2 months after the device implantation.The physician wishes the evaluation of the device memory.
Additional Manufacturer Narrative
Upon receipt, the icd and the lead were still connected.The connections were checked, and the lead was properly attached to the icd header.The lead was found fragmented 46.5 cm distal to the df4 connector pin.The proximal fragment was received for analysis.The distal fragment including the lead tip and rv shock coil was not returned.Cuts into the insulation were found 22 cm and 40 cm distal to the df4 connector pin.Further analysis of the returned lead fragment did not reveal any irregularity.The icd was extensively analyzed.The memory content of the icd was inspected, showing a normal device function while implanted and in service.The iegms from episodes 26, 27 and 34 show a degenerating heart signal.The unavailable episodes were documented as nst.These were overwritten by newer episodes due to memory storage availability and can therefore not be retrieved.This represents a normal device behavior.In a next step, a sensing test was performed, and the device sensed the attached heart signals free of noise.The icd was subjected to an electrical analysis.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 correct sensing and shock delivery.In particular, the specified energy level was reached.The quality documents accompanying the manufacturing processes for these devices were re-investigated.All production steps were performed accordingly, and in particular the final acceptance tests proved the functions of the devices to be as specified.In conclusion, the icd proved to be fully functional.The analysis of the memory content showed a normal device behavior while the device was implanted and in service.There was no indication of an icd or lead malfunction.No irregularities of the lead or icd were noted that might have contributed to the reported event.Analysis did not reveal any sign of a material or manufacturing problem.Biotronik would like to thank you for supporting our post market surveillance program as we continue to monitor, assess and manage complaints associated with our devices.

• Brand Name: RIVACOR 5 VR-T DF4 PROMRI
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15019823
• Report Number: 1028232-2022-03617
• Device Sequence Number: 6856740
• Product Code: LWS
• UDI-Device Identifier: 04035479156916
• UDI-Public: 04035479156916
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 09/30/2023
• Device Model Number: 429565
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2021
• 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