BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3625084 · Received February 12, 2014

    Report

    Report Number
    3004209178-2014-02900
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Report Date
    February 10, 2014
    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
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V914059, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED ON (B)(6) 2013 THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD HELPED ¿SOME¿ SINCE IMPLANT, BUT AT BEST HE HAD BEEN ABLE TO GO FOUR TO FIVE HOURS IN THE NIGHT BETWEEN URINATING. THE PATIENT WAS ON GROUP 3 AT 1.2 AND WAS URINATING ONCE EVERY ONE TO TWO HOURS. THE PATIENT STATED THAT HE WOULD TRY SWITCHING PROGRAMS AT A LATER TIME. ABOUT A YEAR LATER IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT STATED THAT HE DID NOT THINK THE PROGRAMMER OR THERAPY WAS DOING ANYTHING FOR HIM. THE PATIENT THOUGHT THAT BOTH WERE NOT WORKING AND THAT ONE OUT OF THE FOUR CONTACTS WAS NOT WORKING. THE PATIENT FELT THAT IT WAS QUESTIONABLE IF THE THERAPY EVER WORKED. THE PATIENT FELT HE REALLY STARTED HAVING ISSUES ¿ABOUT SIX MONTHS AGO.¿ THE PATIENT HAD THE DEVICE PROGRAMMED ONE OR TWO TIMES. THE PATIENT STATED THAT HE SAW THE MANUFACTURER REPRESENTATIVE AROUND (B)(6) 2013 AND HE WAS INFORMED THAT ¿IT WAS NOT DOING ANYTHING.¿ THE PATIENT WANTED TO SEE A REPRESENTATIVE AGAIN TO HAVE IT LOOKED AT, BUT WAS TOLD HE NEEDED TO SEE A HEALTHCARE PROVIDER (HCP). THE PATIENT NOTED THAT HE HAD NEVER FALLEN OR HAD ANY TRAUMA. THE PATIENT WAS ASSISTED WITH THE PROGRAMMER AND WAS ON PROGRAM 1 AT 1.2 VOLTS AND FELT NOTHING. THE PATIENT TRIED INCREASING STIMULATION, BUT STILL FELT NOTHING UNTIL HE REACHED HIS UPPER LIMIT AT 8.5. THE PATIENT NOTED THAT HE NEVER WENT ABOVE 1.5 OR 1.8 VOLTS BEFORE. THE PATIENT FELT STIMULATION IN THE BIKE SEAT AREA ON PROGRAM 3 AT 0.3 VOLTS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93721 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Male