BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2965093 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02133
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL AND DISTAL CONDUCTORS BOTH HAD BLOOD (NOT OBSTRUCTED) AND WERE DISTORTED FROM BEING PULLED/STRETCHED/OVERSTRESSED. THERE WAS ALSO APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD BODY APPEARS TO HAVE BEEN TORN FROM THE PROXIMAL END OF THE LEAD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 4271 COMPETITOR IMPLANTABLE PACING LEAD, 0145 COMPETITOR IMPLANTABLE TACHY LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED AND HAD NO CAPTURE. WHEN THE POCKET WAS OPENED AND AFTER DISSECTING INTO IT, IT WAS DISCOVERED THE LV LEAD HAD AN OUTER INSULATION FAILURE. THE LV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69344 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR