BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5094639 · Received September 22, 2015

    Report

    Report Number
    3004209178-2015-18422
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    January 31, 2012
    Report Date
    January 9, 2017
    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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V850461, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED THE FOLLOWING DEVICE CODE IS RELATED TO THIS EVENT: THE FOLLOWING DEVICE CODE IS NOT APPLICABLE TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED AS PATIENT CALLED IN STATING THAT THE INTERSTIM SYSTEM HAD BEEN IMPLANTED FOR THE WRONG REASONS. PATIENT HAD INTERSTITIAL CYSTITIS AND THEIR ORIGINAL HCP IMPLANTED HER FOR IT. THE THERAPY DID NOT HELP HER, SO NOW THEY WERE GOING TO HAVE THE SYSTEM REMOVED ON (B)(6) 2016.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED AS PATIENT REPORTED THAT THEY HAVE TOTAL SYSTEM EXPLANTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A LOSS OF THERAPY. SHE HAD INTERSTITIAL CYSTITIS (IC), AND HER SYMPTOMS WERE BACK TO THE WAY THEY WERE BEFORE SHE GOT THE DEVICE. THERAPY WAS ON PROGRAM 1 AT .3 VOLTS AND SHE FELT STIMULATION. HER SYMPTOMS INCLUDED A LOT OF BLADDER AND PELVIC PAIN, URETHRA BURNED AND WOULD HURT, AND SHE COULD NOT GO TO THE BATHROOM AND HAD TO HOLD IT, AND IT BURNED WHEN SHE HAD TO GO. THE CHANGE IN THERAPY AND SYMPTOMS WAS CONSIDERED SUDDEN. OTHER TIMES WHEN SHE HAD FLARE UPS IT WOULD COME ON SLOW. HOWEVER, SHE WOKE UP WITH THIS PROBLEM. LAST TIME SHE HAD A FLARE UP THE DOCTOR GAVE HER MEDICATIONS THAT MADE HER SICK. THIS TIME SHE GOT URICALM, WHICH HELPED SYMPTOMS BUT ONCE OUT OF HER SYSTEM THE SYMPTOMS RETURNED. THE DOCTOR HAD TO RESET THE SETTINGS A COUPLE OF TIMES WHEN SHE FIRST GOT IT. THE OTHER FLARE UPS HAVING BEEN OCCURRING SINCE (B)(6) 2012. IT WAS NOTED THAT THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDES GASTROINTESTINAL/PELVIC FLOOR. THE PATIENT LATER REPORTED THAT SHE WAS HAVING MORE IC FLARE UPS AND MORE BLADDER COMPLICATIONS (SERVE PAIN) AS HE WAS BEFORE SHE GOT THE IMPLANT. THE PATIENT WANTED TO GET THE BATTERY CHECKED TO SEE IF IT NEEDED CHANGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625149 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention