BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2674128 · Received July 30, 2012

    Report

    Report Number
    3004209178-2012-06229
    Event Type
    Malfunction
    Date Received
    July 30, 2012
    Report Date
    July 3, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V183295, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION HAD INCREASED VERY HIGH TO THE POINT WHERE THE PATIENT COULD NOT MOVE. THE STIMULATION WENT DOWN HER LEG AND PELVIC AREA WHILE SHE WAS STANDING BY A SECURITY GATE. STIMULATION WAS INTERMITTENT. THE PATIENT HAD STOOD AT THE SECURITY GATE FOR 5 MINUTES BEFORE THE EVENT OCCURRED. IT WAS STATED THAT "IT CALMED DOWN" AFTER SHE MOVED AWAY FROM WHERE SHE STOOD. THE PATIENT WENT HOME AND THE SENSATION HAD EASED. THE NEXT MORNING THE PATIENT FELT THE SAME "RUSH," BUT IT WAS NOT AS INTENSE AS THE DAY BEFORE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF ABOUT 2 WEEKS AGO AND THE PATIENT DIDN'T KNOW WHY. THE PATIENT WENT THROUGH HOME DEPOT ABOUT 1 MONTH AGO AND IT WAS ACTING FUNNY AND HER LEGS WERE JUMPING WHILE SHE WAS BY THE METAL DETECTOR. TWO WEEKS AGO, THE PATIENT STATED "THE BATTERY WAS TURNED ON IT WAS LIKE SHE HAD A FRIED CROTCH." THE PATIENT FELT SORE AROUND THE INCISION. 1.7 WAS THE HIGHEST PROGRAM THE PATIENT HAD. IT WAS CHANGED TO 1.1 AND IT WAS NOT HELPING ENOUGH. PATIENT PROGRAMMER'S BASIC FUNCTIONALITIES WERE REVIEWED WITH PATIENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STIMULATION TURNED OFF ONCE WHILE AT AN AUTO PARTS STORE AND THEY WERE STANDING NEAR THE ENTRY DOOR. THIS TOOK PLACE IN 2011. NO OUTCOME OR INTERVENTIONS 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.

    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