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

Model Number	429535
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approx.One month after the implantation the device detected supraventricular tachycardia (svt) instead of ventricular tachycardia (vt).Patient was symptomatic.
Additional Manufacturer Narrative
The icd 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 on the returned device data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the icd functions to be as specified.The returned device data have been analyzed.The analysis did not show any anomalies.The programmed parameters were inspected and analysis revealed that the icd functioned as expected according to the programmed parameters.There is no indication of an icd malfunction.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of a device malfunction.

• Brand Name: RIVACOR 7 VR-T DX DF4 PROMRI
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11337681
• Report Number: 1028232-2021-00764
• Device Sequence Number: 13658972
• Product Code: LWS
• UDI-Device Identifier: 04035479156800
• UDI-Public: 04035479156800
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 429535
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1