BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA 300 SR

    MDR report key: 1792365 · Received August 11, 2010

    Report

    Report Number
    6000094-2010-01478
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 4, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DEVICE COULD NOT BE INTERROGATED. DIFFERENT PROGRAMMERS WERE USED, BUT TELEMETRY COULD NOT BE OBTAINED, AND THERE WAS NO PACING RESPONSE TO THE MAGNET. FOLLOW-UP INFORMATION WAS LATER RECEIVED REPORTING THE ACTIVE DEVICE IN THE ABDOMEN WAS FUNCTIONING. HOWEVER, THE INTERROGATION ATTEMPT HAD BEEN ON THE INACTIVE DEVICE, LOCATED IN THE CHEST. THE DEVICE REMAINS IN USE AND WAS REPORTED TO BE FUNCTIONING FINE. NO PATIENT COMPLICATIONS WERE 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 S.A. SSR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other 4965 IMPLANTABLE PACING LEAD| 5867 X 2 IMPLANTABLE LEAD ADAPTOR