BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3770088 · Received April 24, 2014

    Report

    Report Number
    6000032-2014-00077
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    June 23, 2016
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-33, LOT# V457457, IMPLANT ED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889, LOT# J0235430V, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT TOLD HER THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿DOESN¿T DO ANYTHING¿ AND THAT SHE ¿DOESN¿T FEEL IT WORKING.¿ THE HCP WAS AN OCCUPATIONAL THERAPIST WHO SPECIALIZED IN PELVIC FLOOR. THE HCP WAS GOING TO CALL THE DOCTOR FOR MORE INFORMATION. THE HCP THOUGHT THE ISSUE HAD BEEN OCCURRING SINCE IMPLANT IN 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE WAS NOT WORKING. IT WAS NOTED THE PATIENT WAS COMPLETELY INCONTINENT. IT WAS REPORTED THE PATIENT WAS IN PAIN. IT WAS NOTED THE PATIENT WAS ABLE TO INCREASE AND DECREASE STIMULATION. IT WAS REPORTED THE PATIENT WANTED TO KNOW IF THEIR LEADS HAD MOVED. IT WAS NOTED THE PATIENT FELT TWO ¿WIRE BUMPS¿ ON THEIR BACK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS ALSO REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAVE SOUGHT FURTHER HELP. IT WAS REPORTED "THERE IS NO HELP FOR ME". THE PATIENT STATED THAT THE HEALTHCARE PROVIDER TOLD HER "YOU ARE BROKE AND YOU CAN'T BE FIXED". IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ASSISTANCE FROM THEIR HEALTHCARE PROVIDER OR FACILITIES. WHEN IT WAS APPARENT THAT THIS WAS NOT WORKING, THE HEALTHCARE PROVIDER SUGGESTED BOTOX. HOPING FOR SOME CONTROL, THE PATIENT HAD IT DONE, AND SUFFERED FROM THE WORST SIDE EFFECTS THE PATIENT HAD EVER HAD FOR TWO YEARS. AFTER TWO YEARS, OF ABSOLUTELY NO CONTROL AND LOTS OF PROBLEMS, THE PATIENT TRIED MY INTERSTIM, AND WENT THROUGH THE CEILING. IT HURTS. THE PATIENT VAGINA, ANUS, EVERYTHING THEY CAN MENTION HURT BADLY. NO MORE BUBBLING SENSATION. PURE UNADULTERATED PAIN NO MATTER WHAT THE SETTING. THE PATIENT WENT TO ANY SETTING AND COULD NOT STAND UP. THE PATIENT HAVE TURNED IT OFF, AND USING 4-6 DIAPERS A DAY. THE PATIENT WAS AS DISABLED AS SOMEONE WHO CANNOT HEAR OR SEE. THE PATIENT CAN'T WORK. THE PATIENT CAN'T GO FOR A WALK, THE PATIENT CAN'T GO TO A PLAY OR MOVIE. THE DIAPERS DO NOT CONTAIN THE WILD EXPULSION OF WATER THAT THE PATIENT EXPERIENCE. IT GOES OVER THE TOP OF THE DIAPER. THE PATIENT HAVE NO WARNING. IT JUST GUSHES OUT. EVERY WEEK THE PATIENT WASH AT LEAST 12 PAIR OF SLACKS. THE PATIENT HAVE A SPECIAL PADS IN THEIR CAR. THERE WERE TIMES WHEN THE PATIENT WAS SO DISCOURAGED THAT THEY CRIED. THE PATIENT STILL HAVE PAIN FROM WHERE THE INITIAL INTERSTIM WAS INSERTED, AS WELL. (THIS WAS ONE OF THE REASONS THE PATIENT WANTED IT MOVED.) THE PATIENT HAVE TWO BUMPS ON THEIR BACK FROM WIRES. THE PATIENT GUESS THEY JUST HAVE TO GIVE UP, AND KEEP THIS NEAT LITTLE DEVICE QUIESCENT IN THEIR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248639 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1