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

Model Number	354807
Medical Device Problem Codes	Pacing Problem (1439); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intrinsic lv events falling into a refractory period followed by pacing on the lv channel were observed.Patient later needed rv lead revision; in the course of laser extraction of rv lead, this lead was damaged and ultimately explanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 18 cm distal to the is-1 connector pin.Both fragments were received for analysis.Explantation aids were still inserted in and mounted on the distal lead fragment.It is reasonable to assume that the lead was cut during the extraction procedure.The returned lead fragments were visually and electrically analyzed.The visual inspection revealed that the insulation was, apart from the present fragmentation and extraction damages, free of breaches.During the electrical analysis, the dc resistances of the received conductor fragments were measured.No peculiarities were found.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observation.Additional damages, like several cuts into the insulation of the distal lead fragment and the stretched distal fragment, most likely occurred during the extraction procedure.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 85-BP
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10112845
• Report Number: 1028232-2020-02255
• Device Sequence Number: 3406064
• 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: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2020

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: 03/31/2016
• Device Model Number: 354807
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 02/02/2021
• 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: 73 YR