BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2964370 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01363
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 19, 2012
    Report Date
    February 11, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING THE IMPLANT PROCEDURE TWO LEFT VENTRICULAR (LV) LEADS WERE ATTEMPTED AND NOT USED. THE FIRST LV LEAD HAD MUSCLE STIMULATION AND THEN DISLODGED. THE SECOND LV WAS NOT USED DUE TO DISLODGEMENTS. A DEVICE AND RIGHT VENTRICULAR LEAD WERE IMPLANTED; AN LV LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68203 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR