BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1921750 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12680
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 10, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY: (B)(4) OUTER INSULATION BREACHED CUT; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID IN/ON ALL CONDUCTORS (NOT OBSTRUCTED). APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS MUSCLE STIMULATION AND THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLDS. IT ALSO WAS REPORTED THAT THE LEAD INSULATION BREACHED WHEN REMOVED. THE LEAD WAS REPLACED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 3830 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD