BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AT500

    MDR report key: 1924281 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02247
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALAYZED AND THE OUTER INSULATION WAS BREACHED AND HAD A DEPRESSION. IT WAS NOTED THAT ALL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED) AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS REMOVED AND REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR AND/OR "OCCULT DEFECT". IT WAS ALSO REPORTED THAT THE VENTRICULAR LEAD INSULATION WAS BREACHED WHEN THE PHYSICIAN PULLED UP ON THE LEAD DURING THE DEVICE REPLACEMENT. THE LEAD WAS PARTIALLY REMOVED 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 AT500 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. AT501 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD