MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW 85-BP; LV LEAD

Model Number	354807
Medical Device Problem Codes	Intermittent Capture (1080); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
This lead was explanted and replaced due to high thresholds.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut.Only the distal fragment which was elongated up to 110cm length was received for analysis.The proximal fragment including the is-1 connector was not received for analysis.The returned lead fragment was visually and electrically analyzed.The visual inspection showed several cuts in the insulation and deformations of the conductor coil which most likely resulted from the extraction procedure.During the electrical analysis, the dc resistances of the received conductor fragment were measured.No peculiarities were found.Further analysis of the returned lead fragment did not reveal any irregularity that may have contributed to the reported clinical observations.The manufacturing process for this lead 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 85-BP
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8781186
• Report Number: 1028232-2019-02739
• Device Sequence Number: 2014435
• Product Code: OJX
• UDI-Device Identifier: 04035479093549
• UDI-Public: 04035479093549
• 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: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2019

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: 354807
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/11/2019; 10/10/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 07/17/2019; 10/14/2019
• 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: 52 YR