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

Model Number	355148
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reported out of range impedance measurements (>2000 ohms) on home monitoring.Out of range values were not reproduced with isometrics and postural testing in office, however an impedance rise of approximately 300 ohms was observed with the patient lying on their side.Oversensing was also noted.Device was programmed aair in order to avoid using this lead per the physician.Lead remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
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-S 75-BP
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11596750
• Report Number: 1028232-2021-01548
• Device Sequence Number: 17012710
• Product Code: OJX
• UDI-Device Identifier: 04035479094157
• UDI-Public: 04035479094157
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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 Model Number: 355148
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR