BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPICARDIAL PATCH

    MDR report key: 2131644 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00912
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    December 1, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DEFIBRILLATOR CONDUCTOR WAS STRETCHED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS APPARENT EXPLANT DAMAGE. IT WAS NOTED THAT ONLY VISUAL ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE ON THE HIGH VOLTAGE COIL OF THE LEAD. IT WAS LATER REPORTED THAT THE LEAD "SNAPPED IN HALF NEAR THE POCKET". IT WAS REPORTED THE LEAD WAS PARTIALLY EXPLANTED, CAPPED, AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE ON THE HIGH VOLTAGE COIL OF THE LEAD. NO INTERVENTION REPORTED. LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICARDIAL PATCH IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6721M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| O| R 5071 X4 IMPLANTABLE PACING LEAD| 5866M X2 IMPLANTABLE LEAD ADAPTOR| 5071 X4 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5866M X2 IMPLANTABLE LEAD ADAPTOR| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB