BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 SR

    MDR report key: 3861675 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01422
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION. FURTHER ANALYSIS INDICATED THAT THE RETURNED DEVICE REVEALED LIFTED HYBRID BOND WIRES. THE POR WAS DUE TO LOW BATTERY SUPPLY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE DEVICE CHANGEOUT FOR ELECTIVE REPLACEMENT INDICATOR (ERI), THERE WAS AN ERROR MESSAGE INDICATING AN ELECTRICAL RESET. THE DEVICE WAS REMOVED AND REPLACED. IT WAS ALSO NOTED THAT THERE WAS A LOSS OF CAPTURE. THE LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341566 SIGMA 200 SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SSR203U

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R 4023 LEAD