BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3021247 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04231
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 6, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3080, LOT# L70250, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS "NOT WORKING." AND IT WAS THOUGHT THAT "IT QUIT." IT WAS ALSO REPORTED THE PATIENT COULD NOT LOSE WEIGHT, HAD FIBROID UTERINE TUMORS, LUNG TUMORS, HEART PROBLEMS ("60% OPERATIONAL"), AND WAS ALLERGIC TO "IBT" DYES. THE PATIENT'S FEET WERE REPORTED TO HAVE BEEN SWELLED WITH A LOT OF FLUID WITH A BURNING SENSATION ON THE TOP OF THE FEET. THE PATIENT WAS ON DIURETICS. THE PATIENT'S FEET "WERE LIKE THAT" PRIOR TO GETTING THE INS IMPLANTED. THERE WAS NO CLEAR DEVICE RELATION REPORTED REGARDING THE PATIENT'S HEALTH ISSUES. THE PATIENT WAS SEEKING A PHYSICIAN FOR FOLLOW UP WITH THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124591 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1