BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4102540 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17390
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 26, 2014
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-33, LOT# VA0EN32, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_PT M_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD FALLEN SEVERAL TIMES, HAD FALLEN ON THE IMPLANTABLE NEUROSTIMULATOR (INS), AND SHE WONDERED IF THAT WAS THE REASON SHE WAS HAVING PROBLEMS AT NIGHT. THE PATIENT HAD TO GO TO THE BATHROOM AT NIGHT TOO MANY TIMES AND SHE DIDN¿T HAVE THIS PROBLEM RIGHT AFTER IMPLANT. THE FALLS HAD OCCURRED ALL LAST YEAR AND THIS YEAR AS WELL, BUT THEY WERE GETTING BETTER. THE DEVICE WAS UP TO 4 VOLTS AND THE PATIENT WANTED TO KNOW IF THERE WAS ANOTHER PROGRAM THAT WOULD WORK BETTER. THREE WEEKS LATER, THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY BUT WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582721 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR