BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1854638 · Received October 5, 2010

    Report

    Report Number
    2182208-2010-00647
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 17, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD FRACTURED. IT WAS FURTHER NOTED THE PATIENT RECALLED, APPROXIMATELY ONE MONTH PRIOR TO IDENTIFYING THE FRACTURED LEAD, A POP WAS FELT AFTER RAISING THE ARM. THE LV 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 ASKU ASKU DTB MEDTRONIC, INC. ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 5071 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD