BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3153247 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05899
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO THE HIGH IMPEDANCE ON THE SVC PORTION AND ELEVATED THRESHOLDS. AT THE SAME TIME, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO UNEXPECTED BATTERY LONGEVITY. A LEFT VENTRICULAR (LV) LEAD WAS ALSO ATTEMPTED DURING THE PROCEDURE BUT DISLODGED DURING SLITTING AND WAS REPLACED WITH A DIFFERENT 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
    255112 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR