MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 5 VR-T DF4 PROMRI; Implantable cardioverter defibrillator (non-CRT)

Model Number	429565
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approximately 15 months it was reported that low shock impedance was observed.This icd was explanted.
Additional Manufacturer Narrative
The lead under complaint was not returned for analysis.Therefore, this report only refers to the inspection of the quality documents associated with the manufacture of the lead and the icd as well as the analysis of the icd itself.The manufacturing processes for the lead and the icd were re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing of these devices.Particularly, the final acceptance tests proved the devices functions to be as specified.Upon receipt, the icd was interrogated, revealing the bos battery status, 12 charging cycles were recorded in the devices memory.The memory content of the device was inspected.Inspection revealed that 3 shocks were aborted on july 16th, 2022, due to the detection of an external short circuit, which might have otherwise damaged the icd.In a next step, 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, and the measured impedance values were normal.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.A thorough analysis of the icd proved the device to be fully functional.The clinical observation resulted from lead impedance measurements out of range, presumably due to a damage of the rv lead.There was no indication of a material or manufacturing problem of these devices.

• Brand Name: RIVACOR 5 VR-T DF4 PROMRI
• Common Device Name: Implantable cardioverter defibrillator (non-CRT)
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15142260
• Report Number: 1028232-2022-03869
• Device Sequence Number: 14828893
• 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: 2021
• 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): 07/18/2022

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: 07/31/2022
• 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: 08/01/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2020
• 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