BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4377494 · Received January 2, 2015

    Report

    Report Number
    3004209178-2015-00030
    Event Type
    Injury
    Date Received
    January 2, 2015
    Date of Event
    December 4, 2014
    Report Date
    December 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA0N8R3, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD SHOCKING IN THE LOWER BACK, AT THE POCKET SITE, AND IN AN UNKNOWN LOCATION. THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS THAT THE IMPLANT WAS TURNED OFF AND THE PATIENT WAS GOING TO BE SCHEDULED FOR A REVISION. IMPEDANCE TESTING WAS PERFORMED. THE ISSUE WAS NOT RESOLVED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY.

    Description of Event or Problem · 1

    (B)(4) 3176615/ MPXR 223227 (CON/ REP): IT WAS REPORTED THAT THE PATIENT TURNED THEIR STIMULATION OFF FOUR DAYS PRIOR TO REPORT BUT IT FELT LIKE THERE WERE STILL VIBRATIONS COMING FROM IT, LIKE THE STIMULATION WAS TURNED ON. THE PATIENT STATED THIS WAS NOT A PAINFUL SENSATION AND THEY JUST WANTED TO CONFIRM THAT THEY WERE CORRECTLY UNDERSTANDING WHAT THE STIMULATION OFF ICON LOOKED LIKE. IT WAS LATER REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION AND STILL FELT THE BURNING THROBBING SENSATIONS WITH VIBRATIONS EVEN WITH THE DEVICE TURNED OFF. THE PATIENT STATED IT FELT LIKE ¿HER NERVES ARE ON FIRE¿ AND THEY HAD PAIN AND A BURNING SENSATION. HOWEVER, IT WAS WORKING VERY WELL WHEN IT WAS TURNED ON. IT WAS NOTED THAT THE PATIENT¿S DEVICE WAS TURNED OFF AND THE PATIENT WAS WORKING WITH THEIR DOCTOR¿S OFFICE TO BEEN SEEN, HAVE THEIR DEVICE REPROGRAMMED AND HAVE IMAGES TAKEN. THE PATIENT WANTED TO RESOLVE THE ISSUE SO THEY COULD GET IT TURNED BACK ON AND RETURN TO RECEIVING SYMPTOM RELIEF. THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS REPORTED AS ALIVE WITH NO INJURY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention