BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2781771 · Received October 11, 2012

    Report

    Report Number
    2649622-2012-12905
    Event Type
    Injury
    Date Received
    October 11, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION WAS BREACHED AND HAD ENVIRONMENTAL STRESS CRACKING. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL AND PROXIMAL CONDUCTORS (NOT OBSTRUCTED). ALSO, THE OUTER INSULATION WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    THE LEFT VENTRICULAR (LV) WAS RETURNED TO THE MANUFACTURER WITH NO REASON FOR REPLACEMENT. THE LV WAS ANALYZED AND TESTED OUT OF SPECIFICATION. FOLLOW UP DETERMINED THAT THE LEAD WAS EXPLANTED AND REPLACED AS PART OF A DEVICE UPGRADE. 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 57 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD