BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY STRAIGHT

    MDR report key: 4161740 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11442
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    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. CONCOMITANT PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2003; A 694765 LEAD, IMPLANTED: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR RECENTLY IMPLANTED LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THIS WAS CONFIRMED BY THEIR FOLLOWING PHYSICIAN. NO INTERVENTION WAS PERFORMED OR PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639357 ATTAIN ABILITY STRAIGHT DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR DTBA1D1 ICD