MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 5 VR-T DF4 PROMRI

Model Number	429565
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.34 months, it was reported that the patient was admitted to the hospital with an ongoing vt.It was observed that the icd did not identify the vt as such and did not deliver therapy.
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 device functions to be as specified.The returned follow-up data from on (b)(6) 2022 have been analyzed.A total of (b)(4) episodes were documented.Analysis showed that episode nr.27281 from on (b)(6) 2022 from 09:14 h until 10:46 h was detected as svt by the icd, because the stability criterium was not met due to unstable rr-intervals.Please note that the morphmatch function is at work only if an initial vt-detection occurs, meaning if the onset and stability criteria are both fulfilled.Unstable rr-intervals were also noticeable in episodes nr.27276 and nr.27280.Analysis showed that the icd functioned as specified according to the programmed parameters and heart rhythm of this patient.We regret any inconvenience the user might have experienced during this event.The information you have provided has been entered our quality system and will be considered to improve future device generations.

• Brand Name: RIVACOR 5 VR-T DF4 PROMRI
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15180788
• Report Number: 1028232-2022-03952
• Device Sequence Number: 5809131
• Product Code: LWS
• UDI-Device Identifier: 04035479156916
• UDI-Public: 04035479156916
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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: 04/30/2021
• Device Model Number: 429565
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/07/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• 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