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

Model Number 354807

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2023

Event Type  malfunction  

Event Description

The device this lead was placed in was @ eri and gen change was due.At the time of gen change, the physician unscrewed the set screw to loosen the lv lead to place into new device.When he pulled the lv wire out of the header, the silicone came back, but the pin of the lead remained in the header, exposing the internal wires of the lead.Physician was able to carefully remove the pin out of header, advanced some of the internal wire into the silicone shell, while leaving some internal wires exposed, he then plugged the lead into the new device.Prior to securing the lv lead into the header, tested the lead via the psa and had stable threshold @ 1.1v and stable impedance.This lead is still implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: COROX OTW 85-BP
• Type of Device: 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: 16326499
• MDR Text Key: 309094267
• Report Number: 1028232-2023-00684
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 354807
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male