BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PERMANENT PACING LEAD

    MDR report key: 19223002 · Received May 1, 2024

    Report

    Report Number
    1035166-2024-00046
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    November 2, 2006
    Report Date
    May 1, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    PMA / PMN Number
    K964107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IMPLANT DATE IS (B)(6) 2001. THE DEVICE WAS IN SERVICE FOR APPROXIMATELY 5 YEARS, 8 MONTHS BEFORE BEING ABANDONED/CAPPED ON (B)(6) 2006. BASED UPON THE IMPLANT DATE OF THIS LEAD (2001) THE DEVICE HISTORY RECORD FOR THIS LEAD MODEL IS BEYOND OSCOR'S RECORD RETENTION PERIOD. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. NO PRODUCT WAS RETURNED TO OSCOR INC. FOR EVALUATION; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. 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.

    Description of Event or Problem · 0

    (B)(6) 2024: THE CUSTOMER REPORTED THAT LEAD 4018/BIQ20744 WAS CAPPED ON (B)(6) 2006 DUE TO PRODUCT PERFORMANCE ISSUE. (B)(6) 2024: ADDITIONAL DETAILS PROVIDED UNDER COMPLAINT #(B)(4); BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE PACEMAKER CHANGEOUT PROCEDURE THIS VENTRICULAR LEAD WAS SURGICALLY ABANDONED DUE TO THE IMPEDANCE MEASUREMENTS DECREASING FROM 440 OHMS, A YEAR AGO, TO 200 OHMS, WITH HIGH THRESHOLD MEASUREMENTS. THE SENSING FUNCTION WAS STABLE. THE TECHNICAL SERVICES CONSULTANT SUSPECTED AN OUTER INSULATION ISSUE WITH THE REPORTED MEASUREMENTS. THE LEAD WAS SURGICALLY ABANDONED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE ABANDONED LEAD WILL NOT BE RETURNED FOR ANALYSIS; THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THIS CLINICAL OBSERVATION. IMPEDANCE GONE FROM 440 LAST YEAR TO 200 THIS YEAR ALONG WITH HIGH THRESHOLDS, SENSING STABLE. RESPONSE SUSPECTS OUTER INSULATION ISSUE WITH OVERALL IMPEDANCE LOW AND DROP FROM LAST YEAR. SUGGESTED UNIPOLAR TESTING TO EVAL THRESHOLDS IN UNIPOLAR AS WELL AS IF BETTER IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2134701 FLEXION PERMANENT PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. 4018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention