BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2925800 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00851
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 7, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V436021, EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3889-28, LOT# V436 021, IMPLANTED: 2010-(B)(6), EXPLANTED: 2013-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V436021, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS HAVING DIFFICULTY SLEEPING DUE TO LACK OF SYMPTOM CONTROL, WHICH WAS FREQUENTLY GOING TO THE BATHROOM. THE PATIENT COULD FEEL STIMULATION, BUT WAS 'GOING THROUGH PADS.' STIMULATION WAS INCREASED FROM 1.0V TO 1.1V, BUT THE PATIENT 'DID NOT LIKE THAT.' THERE WAS NO KNOWN SPECIFIC TIME WHEN THE SYMPTOMS STARTED. WHEN ADJUSTMENTS WERE ATTEMPTED WITH THE PROGRAMMER, THE 'LOW BATTERY' SYMBOL WAS SEEN. APPROXIMATELY 6 MONTHS LATER IT WAS REPORTED THAT THE PATIENT WAS 'HAVING ISSUES WITH HER DEVICE' AND REPORTED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT WOULD 'GUSH,' AND IT WAS WORSE THAN EVER. IT WAS UNCLEAR WHAT 'GUSH' MEANT. THE PATIENT STARTED OUT ON PROGRAM 3, THEN 2, AND 4 AT 1.0V, AND IT 'DIDN'T SEEM TO HELP HER.' IT WAS STATED THAT 'IT GOES BACK THAT SHE WAS GUSHING ALL THE TIME.' IT WAS NOT CLEAR WHAT THIS MEANT. IT WAS STATED THAT THE PATIENT FELT LIKE IT WAS WORKING, THEN THE 'NEXT DAY IT SLIDES BACK LIKE THE PROGRAM WASN'T WORKING.' THE PATIENT ALSO FELT 'SORENESS' AROUND THE IMPLANT SITE. IT WAS STATED THAT THE IMPLANT WAS 'CHECKED' AND THAT 'EVERYTHING SEEMED IN PLACE.' NO SPECIFIC TESTS WERE MENTIONED. IT WAS STATED THAT STIMULATION HAD NEVER GIVEN THE PATIENT FULL RELIEF. THE PATIENT GOT SYMPTOM RELIEF WHEN IT WAS FIRST PUT IN AND IT SLOWLY CHANGED, BUT IT WAS UNKNOWN WHEN THE CHANGE OCCURRED. IT WAS STATED THAT THE PATIENT HAD BEEN GOING THROUGH THIS PARTICULAR ISSUE FOR 7 YEARS. THE DEVICE HAD NOT BEEN 'CHECKED' FOR OVER 1-2 MONTHS. IT WAS STATED THAT THE PATIENT WAS IMPLANTED 3 YEARS AGO AND 'IT WORKED FOR A WHILE' THEN THE PATIENT WENT BACK AND WAS GIVEN THE MEDICATION, 'VESICARE.' IT WAS STATED THAT THE PHYSICIAN STATED THERE WAS NO PHYSICAL REASON FOR THE PATIENT TO BE 'GUSHING.' THE PATIENT WAS IMPLANTED FOR AN OVERACTIVE BLADDER AND HAD A HISTORY OF URINARY TRACT INFECTIONS. IT WAS REPORTED THAT STIMULATION 'SOMETIMES WORKS FOR 6-8 HOURS WITH NO DISCHARGE AND THEN WHEN SHE LAYS IN BED SHE GETS UP 4-6 TIMES A NIGHT.' IT WAS STATED THAT THE PATIENT'S BLADDER WALL HAD THICKENED AND SHE WAS 'GOING TO HAVE A PROCEDURE' ON (B)(6) 2013. IT WAS REPORTED THAT A HEALTH CARE PROVIDER RECOMMENDED TAKING THE IMPLANT OUT BECAUSE 'MAYBE THERE WERE ISSUES WITH THE LEADS.' IT WAS STATED THAT X-RAYS MAY HAVE BEEN DONE TO CHECK LEAD POSITION. PATIENT HAD PAIN FROM KNEE AND BACK SURGERIES AND GETS 'INJECTIONS' FOR THIS PAIN. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT. FOR MORE INFORMATION ON A RELATED EVENT, PLEASE REFER TO MANUFACTURER REPORT #3004209178-2013-00847.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT¿S FIRST INS WORKED FOR ¿6 MONTHS OR A YEAR¿ THEN ¿WENT OUT¿. IT WAS ALSO NOTED THAT ONE OF THE LEADS ¿WAS BAD ON THE STIMULATOR¿ AND THAT IT WAS FIXED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30936 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention