BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 100 VVI

    MDR report key: 2053106 · Received April 13, 2011

    Report

    Report Number
    6000024-2011-00015
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    January 31, 2011
    Manufacturer
    MEDTRONIC OF CANADA LTD.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY FOR (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'S IMPLANTABLE PULSE GENERATOR (IPG) DEVICE COULD NOT BE PROGRAMMED. IT WAS ALSO NOTED THAT ELECTROCARDIOGRAM (ECG) SHOWED THE PATIENTS HEART RATE WAS 50 BEATS PER MINUTE. THE IPG WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 100 VVI IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC OF CANADA LTD. SVVI103 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R