BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 SR

    MDR report key: 1924509 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02265
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 28, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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.

    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

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 TO 4 MONTHS AFTER THE DEVICE INDICATED ITS ESTIMATED LONGEVITY WAS AT LEAST 1 YEAR, THE PATIENT PRESENTED AT THE CLINIC WITH A VERY SLOW HEART RATE. IT WAS FURTHER REPORTED THAT THE DEVICE HAD 'CEASED TO OPERATE CORRECTLY AND THE BATTERY WAS BASICALLY FLAT', HAD NO OUTPUT, AND COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 200 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SSR203 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R