BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2952447 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00577
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL AND DISTAL CONDUCTORS WERE KINKED/BUCKLED, THE DISTAL AND PROXIMAL CONDUCTORS HAD BLOOD (NOT OBSTRUCTED) AND THE LEAD HAD APPARENT EXPLANT DAMAGE. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012, 6935M IMPLANTABLE DEFIBRILLATION LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED OVERNIGHT POST IMPLANT. THE PATIENT HAD DIAPHRAGMATIC STIMULATION WHICH WAS UNABLE TO BE AVOIDED WITH PROGRAMMING AND THERE WAS A HIGH THRESHOLD WHEN THE LEAD MOVED. THE LV LEAD WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL LV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56683 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR