BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3133634 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08304
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 24, 2013
    Report Date
    December 4, 2018
    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 PRODUCTS: PRODUCT ID 3889-28, LOT# VA052E7, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS "NOT SURE IF THE LEADS MOVED." THERE WAS PAIN AND STIMULATION INA DIFFERENT LOCATION.THE PATIENT WAS FEELING IT IN THE PIRIFORMIS MUSCLE BY THE SCIATIC NERVE. IT WAS NOTED THAT MUSCLE "JUMPS" AND IT IS "KIND OF PAINFUL.". THIS STARTED ABOUT 2 WEEKS AGO. THE PATIENT DID HAVE A FALL ON HER RIGHT SIDE. SHE THOUGHT SHE BROKE HER HIP BUT SHE DID NOT. IT WAS BELIEVED IT WAS BEFORE THE INS WAS PLACED BUT COULD NOT REMEMBER EXACT TIMING. THE PATIENT HAS TORSION DYSTONIA AND HER BODY BENDS IN DIFFERENT POSITIONS. THE PAIN THE PATIENT WAS EXPERIENCING COULD BE THAT ACTING UP. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. IT WAS REPORTED THAT RIGHT AFTER THEIR DEVICE WAS IMPLANTED THEY FELL REALLY HARD AND THEY THOUGHT THE LEADS HAD MOVED BUT THEY DIDN'T. THE PATIENT REPORTED THE IMPLANT HAD COME OUT OF THE MUSCLE POCKET AND NOW IT STICKS OUT. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237322 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR