MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW 75-BP; LV LEAD

Model Number	354805
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Event or Problem Description
It was reported that the rv lead linox s 65 showed signs of failure already in 2018 and was programmed off then.The lv lead corox otw 75-bp showed signs of failure in the recent past.The decision was made to explant both leads.No biotronik rep was present during this process.Very limited information has been transferred on this case so far.The estimated implantation period of both leads was 140 months.
Additional Manufacturer Narrative
Upon receipt, the leads under complaint were subjected to an extensive analysis.The returned linox s was separated into three fragments.Along the lead fragments multiple signs of wear could be found.In particular 17 cm proximal to the lead tip the insulation was found rubbed through.The characteristics of this damage indicate unexpected, excessive wear on the lead.Thus it is assumed that the lead was subject to severe mechanical stress in the implanted state.Causes for elevated stresses are difficult to determine.An accumulation of different factors may impact wear on the lead.These factors include interaction with atypical tissue, significant cardiac motion due to an adverse lead position including slack, or a potential increased ingrowth which had impact on the maneuverability of the lead.Furthermore, tortuous cardiac anatomy, high patient activity levels, and significant manual labor involving the upper body are known contributing factors the returned corox otw was also returned in a fragmented state.The lead showed multiple extraction damages such as cuts in the insulation or a torn apart insulation 2 cm distal to the is-1 connector pin.The manufacturing process for these devices was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: COROX OTW 75-BP
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10766819
• Report Number: 1028232-2020-04732
• Device Sequence Number: 13737905
• Product Code: OJX
• UDI-Device Identifier: 04035479093532
• UDI-Public: 04035479093532
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/02/2020

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: 04/30/2010
• Device Model Number: 354805
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 04/20/2021
• 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