MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 3 VR-T DF4 PROMRI; Implantable cardioverter defibrillator (non-CRT)

Model Number	429574
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
One day after the implantation, it was observed that the device gets ready for a shock as soon as therapies are enabled.The icd was explanted.
Additional Manufacturer Narrative
The icd was received for analysis.Prior to the analysis of the device, the manufacturing process for this icd was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the device interrogation revealed the bos battery status, two charging cycles were documented to the devices memory.The memory content of the device was inspected, confirming the clinical observation.The available iegms revealed inappropriate vf detections in episodes nr.1 and nr.2.Two charging cycles were performed without shock delivery.In a next step the icd was opened, and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.Further electrical investigations revealed that an integrated circuit of the electronic module was damaged, which caused the faulty vf detections.In conclusion, a damaged integrated circuit on the electronic module was identified as the root cause of the clinical observation.The manufacturing records document a normal device production.It is therefore assumed that the damage occurred after the device shipment, however the date of occurrence was not determinable.

• Brand Name: RIVACOR 3 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: 13766543
• Report Number: 1028232-2022-01277
• Device Sequence Number: 4993393
• Product Code: LWS
• UDI-Device Identifier: 04035479157005
• UDI-Public: 04035479157005
• 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): 03/08/2022

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: 11/30/2023
• Device Model Number: 429574
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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: Hospitalization
• Patient Sex: Unknown