BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 100 VVI

    MDR report key: 2955403 · Received February 11, 2013

    Report

    Report Number
    2647346-2013-00018
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4). THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION. THE LONGEVITY CALCULATION WAS COMPLETED USING NOMINAL SETTINGS AND ACTUAL IMPLANT DURATION. UNABLE TO FUNCTIONAL TEST THE DEVICE AS THE DEVICE WAS RECEIVED WITH THE CONNECTOR HEAD BROKEN OFF. THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION. THE LONGEVITY CALCULATION WAS COMPLETED USING NOMINAL SETTINGS AND ACTUAL IMPLANT DURATION. UNABLE TO FUNCTIONAL TEST THE DEVICE AS THE DEVICE WAS RECEIVED WITH THE CONNECTOR HEAD BROKEN OFF.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US 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). ANALYSIS IS PENDING.

    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 THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY DEPLETED EARLIER THAN EXPECTED. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59802 SIGMA 100 VVI PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MDT PUERTO RICO OPERATIONS CO, MED REL SVVI103

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Hospitalization| R