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

Model Number	355149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dizziness (2194); Discomfort (2330)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was experiencing discomfort, dizziness, and palpitations during biv pacing.Lead was explanted and replaced.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 53 cm proximal to the lead tip.The distal fragment was received for analysis.The proximal fragment was not returned.Further cuts into the insulation were found between 34 cm and 30 cm proximal to the lead tip.The inspection revealed that the insulation was, apart from the present cuts, free of breaches.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observations.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: COROX OTW-S 85-BP
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15417987
• Report Number: 1028232-2022-04739
• Device Sequence Number: 14089607
• Product Code: OJX
• UDI-Device Identifier: 04035479094164
• UDI-Public: (01)04035479094164(17)160430
• 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: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 355149
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female