BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 SR

    MDR report key: 2203509 · Received August 11, 2011

    Report

    Report Number
    2647346-2011-01022
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN NOTED VENTRICULAR FIBRILLATION (VF) WHILE USING CAUTERY OVER THE PACEMAKER. THE DEVICE IS DESIGNED TO SHUNT ENERGY AWAY FROM THE CIRCUITRY AND THAT ENERGY IS SHUNTED DOWN THE LEAD. THE DEVICE AND LEAD WERE 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 SIGMA 200 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SSR203 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R