BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3843108 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09949
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 29, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# V906984, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS STILL HAVING PROBLEMS AND THEY THOUGHT IT WAS BECAUSE THERE WAS STILL PROBLEMS WITH THE NERVES AND THEY NEEDED A SPINE DOCTOR. IT WAS NOTED THE PATIENT¿S DEVICE HELPED QUITE A BIT BUT IT COULDN¿T HELP WITH THE ¿OTHER END¿ WITH THE SPINE AND THEY STILL HAD PROBLEMS WITH THEIR SPINE AND THE NERVES THAT WERE CAUSING IT ON THE ¿OTHER END.¿ IT WAS STATED THE PATIENT¿S DEVICE HAD WORKED A LOT AND IT WAS STILL WORKING TO A CERTAIN EXTENT. REPORTEDLY, IF THE PATIENT WAS JUST SITTING IT WORKED PERFECT BUT IT THEY WERE LIFTING OR REACHING THEN IT DIDN¿T WORK. IT WAS STATED THE PATIENT¿S DEVICE WAS FUNCTIONING FOR THE PATIENT TO AN EXTENT BUT THE OTHER HEALTH ISSUE WAS WITH THEIR SPINE. IT WAS LATER REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. ADDITIONAL INFORMATION STATED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS REPORTED THE PATIENT LOST URINARY RELIEF, WHERE THEY COULD FEEL WHEN THEY NEED TO URINATE. IT WAS NOTED IT HAD BEEN ABOUT A MONTH AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS THE DAY OF REPORT. IT WAS STATED THE PATIENT NEVER HAD A URINARY TRACT INFECTION (UTI) AND THEIR URINE ANALYSIS DID NOT SHOW THAT THEY HAD AN INFECTION. IT WAS REPORTED THE PATIENT DID NOT HAVE THE URINE CULTURE RESULTS. IT WAS NOTED THE PATIENT WAS TOLD BY THEIR DOCTOR THAT THEIR DEVICE COULD CAUSE A UTI. THE PATIENT STATED THEIR DEVICE WORKED FOR THEM UNTIL THEY STARTED TO WORK AND MOVE AROUND. IT WAS NOTED THE PATIENT DIDN¿T REALLY HAVE URINARY RETENTION BUT THEIR PROBLEM WAS THEY HAD A SPASTIC BLADDER THAT CAUSED THEM PROBLEMS WHEN THEY URINATE. THE PATIENT ALSO MENTIONED THEY HAD NERVE DAMAGE IN THEIR BACK THAT WAS AFFECTING THEIR BLADDER FUNCTION. IT WAS NOTED THE PATIENT HAD GONE THROUGH ALL THE PROGRAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322462 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention