BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3020075 · Received March 25, 2013

    Report

    Report Number
    3004209178-2013-04212
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V973529, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS STATED THAT THE PATIENT'S DOCTOR "MADE HER TURN IT OFF, BUT SHE STILL GOT SHOCKS FROM IT AND HAD A LOT OF PAIN IN HER GROIN, AND WHEN SHE SAT ON THAT SIDE IT HURTS." IT WAS NOTED THAT THIS STARTED ABOUT A WEEK OR TWO PRIOR TO THIS REPORT. IT WAS STATED THAT THE PATIENT FELT PAIN WHETHER OR NOT THE STIMULATION WAS ON OR OFF. IT WAS NOTED THAT THE PATIENT HAS TWO KNEE IMPLANTS AND THINKS SHE GOT "SHOCKS THERE TOO." IT WAS NOTED THAT THE PATIENT STATED THAT "EVEN WHEN I WALK IT HURTS AND I LIMP, AND I GOT A CORTISONE SHOT THINKING IT WAS MY HIP, BUT THAT DIDN'T DO ANY GOOD, I STILL HAVE THAT PAIN IN MY LEG." THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121983 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1