BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4557822 · Received March 2, 2015

    Report

    Report Number
    3004209178-2015-03890
    Event Type
    Malfunction
    Date Received
    March 2, 2015
    Report Date
    February 12, 2015
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: CHECKMARK PREVIOUSLY MISSING; MADE CORRECTION IN THIS REPORT. INCORRECTLY UPDATED IN FIRST SUPPLEMENTAL REPORT; SHOULD HAVE BEEN LEFT BLANK. MADE CORRECTION (FROM INITIAL REPORT) IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V802404, IMPLANTED: 2012-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. DRINKING HALF A GLASS OF WATER WAS MAKING THEM GO TO THE BATHROOM THREE TIMES IN A ROW. THE PATIENT WAS URINATING SO MUCH THEY WENT TO THEIR HEALTHCARE PROVIDER. THEIR PROGRAMMER BATTERIES WERE DEAD. THEIR IMPLANT WAS AT TWENTY-EIGHT PERCENT LIFE. WHILE ON THE CALL, THE PATIENT CONFIRMED THAT THE STIMULATOR WAS NOT ON. THE PATIENT WAS ABLE TO TURN STIMULATION ON AND INCREASE TO A COMFORTABLE LEVEL. TWO WEEKS LATER, THE PATIENT WAS STILL EXPERIENCING FREQUENCY. THEY HAD ONLY HAD CONTROL FOR AN HOUR AFTER THE PREVIOUS CALL. IT WAS REPORTED THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY. THE STIMULATOR KEPT TURNING OFF. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PATIENT'S IMPLANT WAS REPROGRAMMED TO "SECOND SET OF OPTIONS" AND THE PATIENT RELEARNED HOW TO USE THE PROGRAMMER. AN IMPEDANCE TEST WAS PERFORMED, BUT NO ISSUES WERE ALLEGED. THE LOSS OF EFFECT WAS NOTED TO BE GRADUAL WITH NO LOSS OF STIMULATION, AND THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141704 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR