BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3981364 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13974
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 9, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3889-28, LOT# VA04DRW, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA04DRW, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A SHOCKING OR JOLTING SENSATION. IT WAS INDICATED SINCE SHE MOVED ON (B)(6) WHEN SHE VISITED THE (B)(6) AT HER NEW LOCATION SHE RECEIVED A SHOCK, THE PATIENT HAD TO BE LET THROUGH A SIDE DOOR. THIS HAD BEEN HAPPENING DURING (B)(6) VISITS SINCE (B)(6) WHEN PATIENT BEGAN USING THAT (B)(6) LOCATION. IT WAS REPORTED THAT THE SHOCK WAS PAINFUL AND MAINLY ON HER LEFT SIDE. THE PATIENT FELT LIKE STIM WENT TO THE HIGHEST LEVEL. IT WAS INDICATED THE PATIENT USUALLY KEPT THE RIGHT SIDE LOW AND DID NOT FEEL THE SHOCKING AS MUCH ON THAT SIDE .IT WAS INDICATED THAT PATIENT FELT PAIN FOR 2 HOURS AFTER A SHOCK SOMETIMES. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT #3004209178-2014-13973

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457986 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR