BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3132390 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08216
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 6, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, LOT# V001175, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND STARTED TO FEEL URGENCY ABOUT 3 WEEKS PRIOR TO THE REPORT BUT ¿IT WASN¿T BAD¿. THE PATIENT REPORTEDLY HAD TO WEAR ¿LIGHT LINER¿. IT WAS NOTED THAT THE PATIENT COULD NOT FEEL STIMULATION AND HAD NOT FELT IT FOR A COUPLE OF WEEKS. IT WAS HOWEVER INDICATED THAT THE PATIENT DIDN¿T ALWAYS FEEL STIMULATION. THE REPORTER INDICATED THAT THE PATIENT FELT A JOLT SOMETIMES, AND SOMETIMES FELT IT IN HER LEG OR TOE. THE REPORTER STATED THAT THE PATIENT NORMALLY TURNED STIMULATION ON IN THE MORNING AND TURNED IT OFF AT NIGHT. THE PATIENT HAD HOWEVER NEVER HAD PROBLEMS WITH THERAPY. IT WAS NOTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE BATTERIES TO THE PATIENT PROGRAMMER (PP) HAD BEEN CHANGED AND THE 9V BATTERY LIGHT WAS SHOWING. HOWEVER, THE IMPLANTABLE NEUROSTIMULATOR (INS) LIGHT WAS NOT ON. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THE PATIENT ALSO UNABLE TO ADJUST STIMULATION IN LATE (B)(6) 2013. REPLACING THE BATTERIES IN THE PROGRAMMER DID NOT RESOLVE THE ISSUE. THE IMPLANTABLE NEUROSTIMULATOR (INS) LIGHT ON THE PROGRAMMER WAS BLINKING, INDICATING THE INS WAS LOW. THE PATIENT WAS TRYING TO TURN STIMULATION ON AT THE TIME BECAUSE THEY WOULD TURN IT OFF AT NIGHT BECAUSE IT WAS "IRRITATING." THE STIMULATION WAS CONFIRMED TO BE ON AT THE TIME. ABOUT A MONTH LATER IN (B)(6) 2013, THE PATIENT DID NOT FEEL STIMULATION AT ALL. IT WAS UNKNOWN IF THE INS BATTERY WAS DEPLETED. THE PATIENT WAS NOT HAVING PAIN OR SYMPTOMS AT THE TIME. INFORMATION RECEIVED AS OF THE DATE OF THIS REPORT INDICATED THAT WHEN THE PATIENT FIRST GOT THE IMPLANT IT "WORKED GREAT" AND THEY WERE GOING TO THE BATHROOM "LIKE THEY WERE A TEENAGER." THE PATIENT'S PROBLEM BEGAN A COUPLE YEARS PRIOR. IT WAS NOTED THE PATIENT WAS NOT FEELING STIMULATION AND THE LAST TIME THEY FELT STIMULATION WAS FOUR YEARS AGO. THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND HAD SLIGHT LEAKAGE. SOME DAYS THE PATIENT CHANGES PADS A LOT. SYMPTOMS WOULD BE "BAD" AT TIMES. DURING THE SUMMER, THE DEVICE WAS AGGRAVATING BECAUSE OF THE SWEATING AND HEAT. THE PATIENT WAS CONCERNS ABOUT HAVING THE DEVICE IMPLANTED BECAUSE OF THE SEIZURES FOR THE PAST THREE YEARS. IT WAS NOTED THE "INS WAS NOT WORKING" AND THE PATIENT WAS UNSURE IF THEY SHOULD HAVE IT REMOVED. IT WAS ADDED THE PROGRAMMER DID NOT WORK AT ONE TIME AND THE PATIENT WAS GIVEN A NEW ONE. ABOUT A WEEK LATER IT WAS NOTED THE PATIENT WAS CONCERNED ABOUT HAVING THE DEVICE IN THEIR HIP. IT WAS INDICATED THE PATIENT REPORTEDLY NEVER HAD THERAPEUTIC EFFECT. A SECOND FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234959 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Other