BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2203737 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12145
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 31, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. EVALUATION SUMMARY: (B)(4) THE FULL 4196 LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED). (B)(4) THE FULL 4076 LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYSTEM UPGRADE, THE LEFT VENTRICULAR (LV) LEAD WAS ABLE TO BE PLACED IN THE VEIN BUT WAS UNABLE TO PACE. ANOTHER LV LEAD WAS PLACED. THE RIGHT VENTRICULAR (RV) PACE/SENSE LEAD WAS ATTEMPTED WHEN IT WAS DISCOVERED THAT THE IMPLANTED RV DEFIBRILLATOR LEAD WAS SHREDDED AT THE TOP. THE RV PACE/SENSE LEAD WAS NOT USED. A NEW DEFIBRILLATOR LEAD WAS PLACED IN THE RV. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD