BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2491374 · Received March 14, 2012

    Report

    Report Number
    3004209178-2012-01565
    Event Type
    Injury
    Date Received
    March 14, 2012
    Report Date
    February 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3889-28, LOT: V896800, IMPLANTED: (B)(6) 2012, EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION AS WELL AS ACUTE PAIN IN THE LEFT HIP, THIGH, BUTTOCK, PELVIS AND BACK. THE PATIENT FELT THE SHOCKING/JOLTING WHEN THE STIMULATION WAS TURNED OFF. THE PATIENT ATTEMPTED TO SEEK HELP ON (B)(6) 2012, BUT THE PHYSICIAN "REFUSED" TO SEE HER SINCE SHE WAS "SEPTIC." THE PATIENT HAS ADDISON'S DISEASE AND WENT SEPTIC ON (B)(6) 2012. THE PATIENT NOTED A RETURN OF SYMPTOMS SINCE THAT TIME AS WELL. THE PATIENT WAS SEEN BY A NURSE PRACTITIONER WHO DETERMINED THE NEUROSTIMULATOR WAS SITTING ON HER HIP BONE AND CAUSING DISCOMFORT. THE NURSE PRACTITIONER SUGGESTED A CT SCAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other