BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3071721 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05224
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006/S002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE PROXIMAL AND DISTAL CONDUCTORS OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE ANALYST COMMENTED, DURING TESTING, THE GUIDEWIRE WAS FULLY INSERTED. A SLIGHT RESISTANCE WAS OBSERVED AT 83 CM, LIKELY DUE TO THE DRIED BLOOD THAT HAD ACCUMULATED DURING THE ATTEMPTED IMPLANT.

    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

    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 DURING AN IMPLANT ATTEMPT, AFTER THE INSERTION OF THE LEAD INTO THE CORONARY SINUS, THE PHYSICIAN WAS UNABLE TO ADVANCE THE GUIDEWIRE OUT THE DISTAL END. THE LEAD WAS REMOVED FROM THE BODY AND THEY WERE STILL UNABLE TO ADVANCE THE WIRE OUT THE END OF THE LEAD. MULTIPLE WIRES WERE TRIED. THE PHYSICIAN STATED THE WIRE WAS GETTING STUCK BY THE RING ELECTRODE. AFTER OPENING A NEW LEAD, THE SAME WIRE ADVANCED EASILY THROUGH THE NEW LEAD AND IT WAS IMPLANTED, NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171655 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR 5076 X 2 IMPLANTABLE PACING LEADS