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

Model Number	354805
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Lead explanted due to increasingly high thresholds and loss of capture.No adverse patient events reported.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 60cm distal to the is-1 connector pin.The proximal fragment was received for analysis.The distal fragment including the lead tip was not returned.The performance of the returned lead fragment was scrutinized.The inspection revealed a deformed is-1 connector pin and cuts into the insulation 42cm and 51cm distal to the is-1 connector pin, which most likely resulted from the extraction procedure.However, a thorough analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported increased thresholds and loss of capture.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.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: 11590888
• Report Number: 1028232-2021-01495
• Device Sequence Number: 17217625
• Product Code: OJX
• UDI-Device Identifier: 04035479093532
• UDI-Public: 04035479093532
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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 Model Number: 354805
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 08/11/2021
• 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
• Patient Age: 71 YR