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 Codes	High impedance (1291); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.20 months, it was reported that after an mri examination loss of pacing and a high pacing impedance was observed.The connection of the lead was checked and the pacing and sensing parameters measured, the lead performed as intended.The icd was explanted.
Additional Manufacturer Narrative
The icd was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the icd was interrogated, revealing the battery status bos.The icd was implanted for 19 months.The memory content of the icd was inspected.During the analysis of the available iegms the occurrence of noise was observed in the far-field channel of episode 17.However, the inspection showed a normal device function while implanted and in service.The header of the icd was visually inspected, revealing no anomalies.The set screw could be easily screwed in and out, there was no foreign material inside the header bore.The set screws showed screw marks on the bottom side indicating that it was tightened during the implantation.There was no indication of a material or manufacturing problem.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.In conclusion, the device was fully functional.There was no indication of a device malfunction.

• 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: 13359916
• Report Number: 1028232-2022-00446
• Device Sequence Number: 14637109
• 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: 2020
• 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): 01/20/2022

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: 10/31/2021
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2019
• 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