BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2983608 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03185
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 8, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V169799, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHILE THE PATIENT HAD BEEN TOLD THE WIRE MOVED THE DOCTOR SAID THAT IT WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT FELT AS THOUGH THE STIMULATION "NEVER REALLY HELPED HER" DESPITE ATTEMPTS AT REPROGRAMMING. IT WAS NOTED THAT IT HAD BEEN OVER A YEAR SINCE THE PATIENT LAST SAW HER MANAGING PHYSICIAN. IT WAS REPORTED THAT THE "WIRE" HAD ALWAYS "MOVED AROUND A LOT," AND IT WAS SUSPECTED THAT MIGHT BE THE CAUSE OF THE ISSUE. IT WAS ALSO REPORTED THAT THE PATIENT WAS UNABLE TO MAKE ADJUSTMENTS EVEN WITH THE ANTENNA ATTACHED. THE REPORTER WAS UNSURE IF THIS WAS DUE TO USER ERROR, A PROBLEM WITH THE PROGRAMMER, OR A PROBLEM WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). TWO WEEKS LATER IT WAS REPORTED FROM THE HEALTH CARE PROVIDER THAT THE CAUSE OF THE EVENT WAS UNKNOWN, BUT THE INS OR BATTERY WAS DEAD. NO INVENTION HAD HAPPENED "YET." IT WAS STATED THAT "IMAGING" WAS DONE THAT SHOWED THAT "ALL WERE INTACT." THE PATIENT EXPERIENCED A CONTINUATION OF FREQUENCY OF URINATION. THERE WAS NO PATIENT HOSPITALIZATION. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86497 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1