BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3130040 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08184
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 1, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V114347, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS URINATING NOW MORE THAN BEFORE SHE HAD THE IMPLANT. WHEN THE PATIENT LAID DOWN AT NIGHT WITHIN THREE MINUTES SHE GOT THE URGE TO GO THE BATHROOM AND WENT TO THE BATHROOM AT NIGHT EVERY THREE TO FIVE MINUTES ABOUT 15 TIMES BEFORE FALLING ASLEEP. THE AMOUNT OF URINE IS NOT CONSISTENT, SOMETIMES A COUPLE OF DROPS AND SOMETIMES MORE AND THEN BACK. THE PATIENT FELT STIMULATION BOTH BY THE IMPLANT AND IN HER VAGINA/BICYCLE SEAT AREA. IT WAS NOTED THAT THE PATIENT HAD ALWAYS GONE TO THE BATHROOM A LOT, BUT IT HAS GOTTEN WORSE. THE SYMPTOMS RETURNED TWO DAYS AGO AND THE PATIENT REPORTED NO FALLS OR TRAUMA. IT WAS INDICATED THAT THE PATIENT WAS BIPOLAR, WAS NOT ON MEDS, AND HER QUALITY OF LIFE WAS SLIM. IT WAS ALSO REPORTED THAT WHEN THE PATIENT PUSHED THE SYNC BUTTON ON THE PATIENT PROGRAMMER SHE SAW THE SPLASH SCREEN THEN THE SYNC SCREEN. IT WAS NOTED THAT THE PATIENT HAD NOT USED THE PROGRAMMER IN A WHILE AND WAS GOING TO GET NEW BATTERIES OVER HER LUNCH HOUR. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN ¿URGE¿ THAT WOULD NOT GO AWAY AND THAT HER ¿BODY WON¿T REST WITH THAT URGE.¿ THE PATIENT WANTED TO CHANGE PROGRAMS AND STATED THAT SHE ONLY HAD THREE PROGRAMS AVAILABLE, THAT PROGRAM 2 WAS ¿INTENSE,¿ AND PROGRAM 1 WAS NOT AS INTENSE. THE PATIENT FELT STIMULATION ON PROGRAM 3 AT 3.3 V. SUPPLEMENTAL INFORMATION RECEIVED FROM THE PATIENT¿S PHYSICIAN INDICATED THAT THE PATIENT NEVER CALLED THE PHYSICIAN AND THE PHYSICIAN HAD NOT SEEN THE PATIENT CONCERNING THIS ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ONLY TIME THE PATIENT HAD A PROBLEM WITH HAVING THE URGE TO GO TO THE BATHROOM WAS WHEN THEY LAID DOWN. THE PATIENT COULD NOT LIE DOWN AND TRY TO REST WITH THE TERRIBLE PAIN THEY WERE HAVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231266 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR