BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1863345 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11390
    Event Type
    Injury
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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) NO ANOMALIES FOUND, HOWEVER LEAD WAS STRETCHED, APPARENT EXPLANT DAMAGE NOTED, AND BLOOD NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED); FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING A NEW RIGHT VENTRICULAR PACE/SENSE LEAD THE LEFT VENTRICULAR LEAD DISLODGED. THIS LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN 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 66 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB