BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 SR

    MDR report key: 1874750 · Received October 19, 2010

    Report

    Report Number
    2647346-2010-00653
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) DEVICE ANALYSIS FOUND NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD REACHED ITS ELECTIVE REPLACEMENT INTERVAL (ERI). IT WAS ALSO REPORTED THAT THERE WAS DIFFICULTY INTERROGATING THE DEVICE DUE TO ELECTRICAL RESET INDICATOR. THE DEVICE WAS REMOVED AND RETURNED AND A NEW DEVICE IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SSR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 5068 IMPLANTABLE PACING LEAD