BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2813009 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15979
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 THE PROXIMAL CONDUCTOR WAS DISTORTED, ALL CONDUCTORS WERE STRETCHED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS MELTED, THE OUTER INSULATION WAS PULLED APART DUE TO OVERSTRESS, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE INNER INSULATION WAS TORN, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AS LEAD DISLODGEMENT. THE 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 OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB