BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 6316969 · Received February 9, 2017

    Report

    Report Number
    2649622-2017-00413
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Date of Event
    December 26, 2016
    Report Date
    December 26, 2016
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: D204TRM ICD, IMPLANTED: (B)(6) 2013-09-27; 407652 LEAD, IMPLANTED: (B)(6) 2013-09-27; MCS-P3-943 TRANSCATHETER VALVE, IMPLANTED (B)(6) 2013.

    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 PATIENT FELT LIKE THEY WERE "SHOCKED" TWO TIMES WHILE SLEEPING. NO SHOCK WAS NOTED ON REMOTE TRANSMISSION. HOWEVER, RISING AND HIGH IMPEDANCE WAS NOTED ON BOTH THE RIGHT AND LEFT VENTRICULAR LEADS. RISING AND HIGH LEFT VENTRICULAR CAPTURE MANAGEMENT THRESHOLD WAS ALSO NOTED. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99144 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 6947M62 LEAD