BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2920908 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00726
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 28, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V915103, 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 REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. THE PATIENT BELIEVED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNING ITSELF OFF. IT WAS NOTED THERE WAS A LOSS OF BLADDER CONTROL THAT STARTED 2 TO 2.5 MONTHS AGO. THE PATIENT STARTED TO NOTICE IT MORE THE LAST TWO WEEKS WHILE THEY HAD BEEN ON A CRUISE SHIP. PATIENT DID NOT THINK THEY HAD TRIED TO MAKE ANY ADJUSTMENTS BUT THEY HAD CHECKED THE STATUS AT TIMES TO FIND OUT WHY THEY WERE HAVING A RETURN OF SYMPTOMS. WHEN THE PATIENT TURNED STIMULATION ON THEY GOT A STRONG JOLT OR SHOCKING SENSATION FROM THEIR ANUS TO THEIR VAGINAL AREA. PATIENT WAS ON PROGRAM 4 AT 2.8 VOLTS DURING REPORT. IT WAS NOTED WHEN THE PATIENT CHECKED THEIR DEVICE THEY PRESSED THE POWER BUTTON AND SYNCHRONIZE KEY. IT WAS ALSO NOTED THE PATIENT HAD LONGER NAILS SO IT WAS POSSIBLE THEY WERE HITTING THE STIMULATION OFF BUTTON AS WELL. PATIENT HAD AN APPOINTMENT WITH THEIR HEALTH CARE PROVIDER (HCP) AT THE END OF OCTOBER BUT DID NOT MENTION THIS. PATIENT STATED THEY WOULD "WAIT AND GIVE THIS ANOTHER MONTH OR SO AND MONITOR IT WHEN PRESSING KEYS." FOLLOW UP REPORTED THE PATIENT RECEIVED ASSISTANCE ON THE PHONE AND THEIR CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26377 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1