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

Model Number	368346
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Cardiac Perforation (2513); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This lv lead was in the process of being explanted for a quadripolar lead in order to eliminate diaphragmatic stimulation when it fractured.During this, the patient started to bleed and part of the lead remained in the patient.The patient was taken to cardiac surgery for the bleed and there may have been a perforation.The surgery was successful.Should additional information be received, this file will be updated.
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.

• Brand Name: COROX OTW-L 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: 16308258
• Report Number: 1028232-2023-00641
• Device Sequence Number: 12283503
• Product Code: OJX
• UDI-Device Identifier: 04035479112172
• UDI-Public: (01)04035479112172(17)180630
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 06/30/2018
• Device Model Number: 368346
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• 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; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male