MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 VR-T DF4 PROMRI; ICD

Model Number 429536

Device Problem Ambient Noise Problem (2877)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2023

Event Type  malfunction  

Event Description

Noise on rv lead.Left side was occluded.Physician wanted a new device since prior unit was three years old.The lead seemed to test fine after it was explanted so they would like an analysis of this device and would like the header checked out to see if it could have contributed to the noise.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Manufacturer Narrative

Upon receipt, the icd was interrogated, revealing the battery status bos.The icd was implanted for 34 months and 10 charging cycles were recorded to the devices memory.The memory content of the device was inspected.During the analysis of the available iegms noise was observed in the right ventricular channel, leading to one charging cycle.Therefore, a sensing test was performed and the device sensed the applied heart signals free of noise, proving the sensing function of the icd to be normal and as expected.There was no indication of a device malfunction.The header of the icd was inspected, revealing no anomalies.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.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed in the right ventricular channel, confirming the clinical observation.However, a thorough analysis of the icd proved the device to be fully functional.There was no indication of a device malfunction.

• Brand Name: RIVACOR 7 VR-T DF4 PROMRI
• Type of Device: 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: 16368669
• MDR Text Key: 309507882
• Report Number: 1028232-2023-00808
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 04035479156817
• UDI-Public: (01)04035479156817(17)210831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 429536
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female