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

Model Number	368345
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11302927
• Report Number: 1028232-2021-00710
• Device Sequence Number: 13635577
• Product Code: OJX
• UDI-Device Identifier: 04035479112165
• UDI-Public: 04035479112165
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 02/15/2021; 05/05/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/17/2021; 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR