MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 VR-T DX DF4 PROMRI; Implantable cardioverter defibrillator (non-CRT)

Model Number	429535
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device interrogation showed an error regarding elevated power consumption.Based on data analysis results it was decided to report the incident.Device remains implanted.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as the returned device data.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.The returned device data of may 10, 2022 have been analyzed.The analysis revealed an elevated current consumption, which was automatically detected by the device, subsequently leading to a programmer notification message.Based on the information available for analysis the root cause of the elevated current consumption could not be determined.Biotronik has informed the health care professional about this analysis result, who decides, based on the patients individual circumstances and medical judgment, if the device will be exchanged.Should further relevant information or the device itself become available, this investigation will be updated.
Additional Manufacturer Narrative
It was reported that this device was explanted on (b)(6) 2022 upon receipt, the device interrogation revealed the eos battery status.A number of three charging cycles was documented.The inspection of the icd memory content confirmed a premature detection of the eos battery status on december 27th, 2022, one month after the icd had been explanted.The current consumption of the device in the eos state was tested and was found to be normal.The icd was subjected to an electrical analysis.First, the eos status was removed with a technical programmer and 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 detected the fibrillation signal as specified and started the charging of a defibrillation shock.However, the shock was not delivered because of the depleted state of the battery.Therefore, the icd was opened to examine the inner assembly.A visual inspection showed no anomalies.The battery voltage was measured confirming a depleted battery.Further extensive analysis of the electronic components and the device memory content was performed, indicating an intermittent elevated current consumption, that could be narrowed down to an integrated circuit on the electronic module.Based on all available information, the root cause for the intermittent elevated current consumption was, however, not conclusively determinable.The current consumption of the icd was normal during analysis.The manufacturing records and quality documents for this device were re-investigated.No anomalies were documented during the device manufacturing, in particular during the final acceptance test no abnormality in the current consumption of the device was observed.

• Brand Name: RIVACOR 7 VR-T DX 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: 14747619
• Report Number: 1028232-2022-03155
• Device Sequence Number: 17387192
• Product Code: LWS
• UDI-Device Identifier: 04035479156800
• UDI-Public: 04035479156800
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2022

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: 04/30/2023
• Device Model Number: 429535
• 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: 06/17/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 03/07/2023
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 07/28/2022; 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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