BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 19254666 · Received May 6, 2024

    Report

    Report Number
    1035166-2024-00049
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Report Date
    May 6, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K964107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED TO OSCOR INC. FOR EVALUATION. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. THE LACK OF LOT TRACEABILITY PREVENTS PERFORMING A DEVICE HISTORY RECORDS REVIEW FOR ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE REPORT RECEIVED VIA THE FDA STATED THE LEAD EXHIBITED AN INCREASED HIGH PACING THRESHOLD MEASUREMENTS AND LOW SENSING. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THIS LEAD IS NO LONGER MANUFACTURED. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    MEDWATCH REPORT MW5153235: IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASED HIGH PACING THRESHOLD MEASUREMENTS AND LOW SENSING. A VENOGRAM WAS TAKEN ON THE LEFT SIDE WHICH SHOWED AN OCCLUDED VEIN. SUBSEQUENTLY, A NEW RIGHT SYSTEM WAS IMPLANTED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763693 FLEXION PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. 4018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown