MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-75; LV LEAD

Model Number	401182
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Lv lead with loss of capture on all poles with unchanged position.Since (b)(6) of 2019 the impedance has been greater than 3000 ohm.The revision was then successfully performed on (b)(6) 2020.
Additional Manufacturer Narrative
The returned lead was thoroughly analyzed.During the analysis, the lead was checked visually and electrically.30 cm distal of the is-1 connector pin, the lead body was severely damaged by squashing and deformation.At this site, a fracture of all helices was detected.This damage is with high probability the cause of the clinical complaint.The observed damage pattern requires excessive pressure load onto the lead body.The characteristics of the damaged structure of the lead body leads to the assumption of excessive mechanical stress of the lead due to the subclavian crush syndrome.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 L-75
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10466480
• Report Number: 1028232-2020-03625
• Device Sequence Number: 2553260
• Product Code: OJX
• UDI-Device Identifier: 04035479138431
• UDI-Public: 04035479138431
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/07/2020

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: 04/30/2019
• Device Model Number: 401182
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 02/10/2021
• 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