MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP S-85; LEAD

Model Number	401180
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approximately 63 months, it was reported that an out-of-range impedance value was detected for the left ventricular lead.The lead was capped.
Additional Manufacturer Narrative
As of today, the medical devices are not available for analysis, therefore the devices themselves could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of these devices as well as on the provided data.The manufacturing processes for these devices were re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing processes.The analysis of the provided iegm episodes revealed artifacts on the rv channel, which led to the reported oversensing as well as inappropriate shocks and icd charging cycles.The analysis of the provided trend data, acquired on the 14-aug-2021 recorded a pacing impedance greater than 3000ohms.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the leads themselves would be necessary to determine the root cause.Should additional information or the devices themselves become available for analysis, the investigation will be updated.

• Brand Name: SENTUS PROMRI OTW QP S-85
• Common Device Name: LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12356675
• Report Number: 1028232-2021-04714
• Device Sequence Number: 3593871
• Product Code: OJX
• UDI-Device Identifier: 04035479138417
• UDI-Public: 04035479138417
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 03/31/2018
• Device Model Number: 401180
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization