BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC.SIGMA

    MDR report key: 2952887 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00159
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 6, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT (ED) WITH A LOW HEART RATE AND FEELING FAINT. THE PHYSICIAN ATTEMPTED TO INTERROGATE THE DEVICE BUT THERE WAS NO TELEMETRY. THE DEVICE WAS 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
    57121 MEDTRONIC.SIGMA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SDR303

    Patients

    Seq Age Sex Outcome Treatment
    1 00096 YR Hospitalization| R