BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3860283 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05459
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED, ELECTRICAL RESISTANCE AND CROSS CONTINUITY TEST RESULTS WERE WITHIN SPECIFICATIONS. NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PATIENT EXPERIENCED PHRENIC NERVE/DIAPHRAGMATIC MUSCLE STIMULATION AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. PER MEDICAL JUDGEMENT THE LV LEAD WAS REPLACED WITH A DIFFERENT LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343350 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR