BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1874719 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11517
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 21, 2010
    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
    MA, 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, FULL LEAD WAS RETURNED IN SEGMENTS. IT WAS ALSO NOTED THAT BLOOD WAS ON THE CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS MELTED AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS ATTEMPTED TO BE REPOSITIONED BUT THIS PROCEDURE FAILED. THE LEAD WAS EXTRACTED AND REPLACED. 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 79 YR Required Intervention D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 1688TC COMPETITOR IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD