BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 100 S

    MDR report key: 2203252 · Received August 11, 2011

    Report

    Report Number
    6000024-2011-00031
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 4, 2011
    Manufacturer
    MEDTRONIC OF CANADA LTD.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1510/1519-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. 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 WAS ADMITTED TO THE HOSPITAL WITH EPISODES OF SYNCOPE. THE DEVICE WAS NOT ABLE TO BE INTERROGATED. A MAGNET TEST CONFIRMED THAT THE DEVICE WAS SUDDENLY AT END OF LIFE. THE DEVICE HAD GOOD BATTERY VOLTAGE THE MONTH PRIOR. THE DEVICE WAS LATER REMOVED 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 100 S IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC OF CANADA LTD. SS103 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R