BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2834320 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10335
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 18, 2012
    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 MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V003327, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THE STIMULATION WAS NOT HELPING WITH FREQUENCY, WHICH HAD OCCURRED FOR THE LAST 3-4 MONTHS. IT WAS STATED THAT ON (B)(6) 2012, THE PATIENT EXPERIENCED SEVERAL "BAD SHOCKS" IN A ROW AND HAD TO TURN OFF THE DEVICE. THE REPORTER ALSO STATED SHE SAW HER HEALTH CARE PROVIDER (HCP) AND WAS INSTRUCTED TO TURN THE DEVICE BACK ON. IT WAS NOTED THAT NO SHOCKS WERE FELT AT THE HCP VISIT. IT WAS STATED THAT THE PATIENT COULD FEEL STIMULATION AND THAT HER NORMAL SETTING WAS AT 1.5 VOLTS. THE REPORTER STATED SHE HAD TO TURN THE STIMULATION UP TO THE 2 VOLT RANGE. IT WAS STATED THAT THE PATIENT WOULD USUALLY GO TO THE BATHROOM 3-4 TIMES A DAY, BUT NOW WENT 10-15 TIMES A DAY. IT WAS FURTHER STATED THAT A SIMILAR EVENT TOOK PLACE ABOUT A YEAR AGO. IT WAS STATED THAT THERE WERE NO FALLS OR TRAUMAS WITHIN THE LAST 3-4 MONTHS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. ANY ADDITIONAL INFORMATION WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1