MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW-L 75-BP; LV LEAD

Model Number 368345

Device Problem Ambient Noise Problem (2877)

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

Event Date 02/09/2021

Event Type  malfunction  

Event Description

Possible noise on lv near field.No far field visible for review.Full lead evaluation recommended.Lead remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

Clinician reported noise on the lead, seen causing crt interrupt recordings on home monitoring.The noise can be recreated when the patient reaches across their torso and pushes their hands together.Clinician will review with physician and continue to monitor the lead.Lead remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.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.

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-L 75-BP
• Type of Device: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11302927
• MDR Text Key: 231023744
• Report Number: 1028232-2021-00710
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 04035479112165
• UDI-Public: 04035479112165
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: 368345
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 02/15/2021; 05/05/2021
• Supplement Dates FDA Received: 02/17/2021; 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR