BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2944481 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01332
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 15, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V430990, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS AND WAS WORKING WITH HER HCP. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED A URINARY TRACT INFECTION AND VULVOVAGINAL CANDIDIASIS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A LOSS OF THERAPEUTIC EFFECT OCCURRED AND THAT PATIENT'S SYMPTOMS RETURNED WITHIN THE LAST MONTH. THE STIMULATION WAS ADJUSTED UP TO 3.0V BUT IT WAS IRRITATING AND CAUSING PAIN SO THE STIMULATION WAS ADJUSTED DOWN TO 2.8V. AT 2.8 VOLTS THE STIMULATION WAS STILL IRRITATING AND CAUSING PAIN BUT THE PATIENT DIDN'T WANT TO ADJUST DOWN ANY FURTHER BECAUSE THEN SHE WAS NOT ABLE TO CONTROL HER URINE. MORE THAN TWO AND A HALF WEEKS LATER IT WAS STATED THAT PATIENT'S DEVICE WORKED WELL FOR 2 YEARS UNTIL 2 WEEKS AGO. SHE WAS ON PROGRAM #1 AND IT WORKED. SHE SAW HER DOCTOR TWO WEEKS AGO AND CHANGED IT TO PROGRAM #2 AND THEN PROGRAM #3. THE PATIENT WAS ON PROGRAM #3 AT 1.6V. IT WAS STATED THAT AT A 1.8V "IT WAS TOO HIGH AND HURT." IT WAS ALSO MENTIONED THAT THE PATIENT WORE A HOLE THROUGH HER SLACKS FROM THE INTERNAL WIRE. SHE CHANGED IT TO BE ON PROGRAM #4 AT A 1.9V. IT WAS STATED THAT THE PATIENT ALSO FELL 6 MONTHS AGO BUT WAS "FINE." ONE WEEK LATER IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, A LOSS OF THERAPEUTIC EFFECT OCCURRED. A LACK IN THERAPY EFFECT WAS NOTICED OVER THE PAST 3 WEEKS OR SO. THE PATIENT HAD TRIED ALL 4 PROGRAMS AVAILABLE TO HER AND NONE HAD BEEN EFFECTIVE AS SHE FREQUENTLY LOST CONTROL OF HER URINE WHEN SHE STOOD UP AND SHE WAS STILL GETTING UP TO USE THE BATHROOM 2-3 TIMES PER NIGHT. IT WAS ALSO STATED THAT IT DIDN'T SEEM LIKE HER BLADDER EMPTIED WHEN SHE DID GO. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SET ON PROGRAM #4 AT 1.5V AND IF SHE TURNED STIMULATION TOO HIGH IT HURT AND STILL DIDN'T HELP CONTROL HER BLADDER. EROSION WAS ALSO REPORTED. IT WAS STATED THAT THE "WIRE" IN PATIENT'S BACKSIDE WAS STICKING OUT. THE PATIENT ALSO FELT SORENESS OR PAIN AROUND THE INS FOR ABOUT THE PAST MONTH WITH NO SPECIFIC KNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49346 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention