BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2402369 · Received January 6, 2012

    Report

    Report Number
    3004209178-2012-00112
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Report Date
    December 20, 2011
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMER MODEL 3037, SERIAL# (B)(4), LEAD MODEL 3093-28, LOT# V244042, IMPLANTED: 2011-(B)(6), EXPLANTED: NA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION. THE HEALTH CARE PROFESSIONAL STATED THE PATIENT HAD A 'VERY GOOD' RESPONSE AND TREATMENT OF HER INCONTINENCE ISSUES, HOWEVER THE PATIENT KEPT SETTING SECURITY ALARMS OFF AND RECEIVING PAINFUL OVERSTIMULATIONS WHILE GOING THROUGH SECURITY SYSTEMS AT MULTIPLE STORES. THE HCP NOTED THE PATIENT DID NOT RETURN FOR ANY ADDITIONAL FOLLOW UP AND THE PATIENT OUTCOME WAS 'NON-SERIOUS INJURY/ILLNESS.'

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. THE PATIENT TRIED TO INCREASE STIMULATION USING THE PATIENT PROGRAMMER BUT WAS NOT ABLE TO MAKE AN ADJUSTMENT WITH OR WITHOUT THE ANTENNA ATTACHED. THE PATIENT DID NOT KNOW WHAT HER AMPLITUDE WAS, BUT STATED IT WAS PRETTY HIGH BECAUSE SHE HAD KEPT TURNING IT UP. IT WAS ALSO REPORTED THAT THE PATIENT USED TO EXPERIENCE AN OVERSTIMULATION SENSATION WHEN WALKING THROUGH THEFT DETECTORS, BUT HAD NOT FELT THAT SENSATION FOR APPROXIMATELY SIX MONTHS. 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
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1