BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBQ

    MDR report key: 1924517 · Received December 14, 2010

    Report

    Report Number
    2182208-2010-00985
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 28, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S021
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS REVEALED THAT THE OUTER INSULATION WAS TORN. THE FULL LEAD WAS RETURNED IN SEGMENTS FOR ANALYSIS. FURTHER TESTING REVEALED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DEFIBRILLATION CONDUCTOR (NOT OBSTRUCTED), THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE LEAD WAS STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS NOTED THAT THE LEAD INSULATION WAS DAMAGED. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBQ IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6996 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention