BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1926066 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14150
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND THE LEAD APPEARED DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS NOT CAPTURING AND WAS CAPPED. A NEW LV LEAD WAS ATTEMPTED BUT WAS NOT IMPLANTED SINCE THE PHYSICIAN WAS NOT ABLE TO GET THE LEAD TO SEAT PROPERLY. ANOTHER LV LEAD WAS IMPLANTED. NO 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 59 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB