BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2012265 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-00829
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION AFTER THE HEALTHCARE PROFESSIONAL REPROGRAMMED THE DEVICE. THE PATIENT WAS AT 3.4 VOLTS WHICH WAS FINE WHEN THE PATIENT WAS STANDING, BUT WHEN SITTING IT WAS TOO STRONG, IT WAS LIKE A "BIG JOLT." THEY HAD TO DECREASE TO 1.3 VOLTS. THE PATIENT WAS AT HOME IN FAIR CONDITION AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD107262N| LEAD: MODEL 3093, LOT# V458555