BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2953677 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01252
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: PRODUCT EVENT SUMMARY: (B)(4) -THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE PROXIMAL AND DISTAL CONDUCTORS HAD BLOOD (NOT OBSTRUCTED).

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEFT VENTRICULAR LEAD PARTIALLY DISLODGED WITH REMOVING THE CORONARY SINUS SHEATH BUT THEN FULLY DISLODGED WHILE TRYING TO REPOSITION THE LEAD. ANOTHER LEFT VENTRICULAR LEAD PULLED BACK AFTER THE CORONARY SINUSSHEATH WAS REMOVED BUT THEN DISLODGED WHILE TRYING TO REPOSITION THE LEAD. NEITHER LEAD WAS USED, AND ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEFT VENTRICULAR LEAD PARTIALLY DISLODGED WITH REMOVING THE CORONARY SINUS SHEATH BUT THEN FULLY DISLODGED WHILE TRYING TO REPOSITION THE LEAD. ANOTHER LEFT VENTRICULAR LEAD PULLED BACK AFTER THE CORONARY SINUS SHEATH WAS REMOVED BUT THEN DISLODGED WHILE TRYING TO REPOSITION THE LEAD. NEITHER LEAD WAS USED, AND ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56376 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR