BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 5129053 · Received October 5, 2015

    Report

    Report Number
    3004209178-2015-20053
    Event Type
    Malfunction
    Date Received
    October 5, 2015
    Report Date
    September 14, 2015
    Manufacturer
    MPROC
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V813549, IMPLANTED: (B)(6) 2011, 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

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE DEVICE WAS CHECKED ON (B)(6) 2015 AND THE MANUFACTURE REPRESENTATIVE SAID IT LOOKED LIKE THE TWO LEADS WERE NOT WORKING RIGHT. AN X-RAY WAS TAKEN TO CHECK THE LEAD PLACEMENTS WHICH SHOWED GOOD RESULTS. THE PATIENT STATED THAT THE X-RAY RESULTS DID NOT MAKE SENSE SINCE SHE FELT LEG CRAMPS HIGH UP IN HER LEG AND TINGLING IN HER BACK AND LEG. THESE SYMPTOMS MADE THE PATIENT SORE, BUT THE SORENESS WENT AWAY WHEN SHE TURNED THE DEVICE OFF. AN APPOINTMENT WAS SCHEDULED FOR (B)(6) 2015 TO TRY DIFFERENT PROGRAMS. SEE MANUFACTURE REPORT NUMBER 3007566237-2015-03413 FOR OTHER LEAD.

    Description of Event or Problem · 1

    A PATIENT INDICATED FOR GASTROINTESTINAL/PELVIC FLOOR REPORTED THE DEVICE ¿DIDN¿T WORK¿ AND THEY WANTED AN APPOINTMENT WITH THE DOCTOR. THEY DID NOT KNOW THE BATTERY WOULD NEED REPLACING. NO FURTHER CLARIFYING INFORMATION OR INFORMATION REGARDING SYMPTOMS OR STEPS TAKEN TO RESOLVE THE ISSUE WAS REPORTED. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE REPORTED AN IMPEDANCE CHECK WAS PERFORMED INITIALLY WHICH CAME BACK FINE. THE PATIENT HAD BEEN GIVEN NEW PROGRAMS AND THE DEVICE WAS REPROGRAMMED PRIOR TO X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659592 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MPROC 3093-28 V813549

    Patients

    Seq Age Sex Outcome Treatment
    1