BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 DR

    MDR report key: 1925083 · Received December 14, 2010

    Report

    Report Number
    2647346-2010-00862
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 30, 2010
    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
    PA, 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) PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM, THE DEVICE WAS INTERROGATED AND WAS UNABLE TO ESTABLISH TELEMETRY WITH PACEMAKER. THE DEVICE HAD NO PACING OUTPUT AND THERE WAS NO EFFECT FROM THE MAGNET. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER 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 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR203 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R 4524 IMPLANTABLE PACING LEAD| 4024 IMPLANTABLE PACING LEAD