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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approx.65 months after the implantation the pacing impedance was over 3000 ohms.A revision took place.
Additional Manufacturer Narrative
The returned lead was thoroughly analyzed.During the analysis, the lead was checked visually, electrically, and mechanically.The analysis found multiple signs of abrasion along the lead body.Especially between 8 and 13 cm distal of the df4 connector pin, the outer insulation was found to be squashed and frayed down to the rope leading to the shock electrode.This damage is with high probability the cause of the observed ineffective shock delivery.The position and kind of the fraying are characteristic for massive mechanical stress of the lead due to strong pressure onto the generator housing with simultaneous frictions against it.In addition, a deformed proximal and distal shock coil was found during the analysis.These damages are probably a result of the extraction procedure.The manufacturing process of this lead was reviewed.The production documents showed no anomalies.All manufacturing steps had been carried out correctly.In summary, there were no indications of a material defect or manufacturing error.

• 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: 10171497
• Report Number: 1028232-2020-02481
• Device Sequence Number: 3361779
• 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: 2014
• Device Explanted 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): 05/28/2020

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: 06/30/2016
• Device Model Number: 401180
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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