BEUDAMED
    FDA Adverse Event Injury Summary report: N

    350 SERIES

    MDR report key: 4160882 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02346
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1516-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POWER ON RESET (POR) AND THE PATIENT EXPERIENCED SYNCOPE WHILE TRAVELING ON A PLANE. THE DEVICE WAS EXPLANTED 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
    640923 350 SERIES PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND DR353

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R