BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3132410 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08221
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 6, 2013
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA0317G, IMPLANTED: (B)(6) 2012, 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

    IT WAS REPORTED THAT THE PATIENT HAD A STROKE AFTER THE DEVICE WAS IMPLANTED BUT DID NOT HAVE AN EXACT DATE. AT THE TIME OF THE REPORT THE PATIENT HAD BEEN OUT OF REHAB FOR THE STROKE FOR THREE TO FOUR WEEKS. IT WAS ALSO REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT HAD BEEN TRYING ¿FOR A LONG TIME¿ BUT WAS UNABLE TO UTILIZE HER PROGRAMMER PROPERLY. THE PATIENT STATED THAT THE DEVICE WAS ¿TOO FAR BACK¿ AND WAS UNABLE TO REACH ¿BACK THERE.¿ THE PATIENT WAS ASSISTED IN SUCCESSFULLY ADVANCING TO THE MAIN SCREEN TWICE BUT WAS UNABLE TO MAINTAIN PROPER COMMUNICATION TO DECREASE SETTINGS PRIOR TO TURNING THE DEVICE ON AS THE CURRENT SETTINGS WERE AT 3.9 VOLTS ON PROGRAM 1 AND HER DEVICE WAS OFF. THE PATIENT FELT THE DEVICE WAS IN HER BODY BUT WAS UNABLE TO REACH IT PROPERLY. THE PATIENT STATED SHE HAD USED ¿IT¿ TWELVE OR THIRTEEN DAYS SINCE SHE HAD ¿IT¿AND USED ¿IT THREE DIFFERENT DAYS AND SATURDAY¿ PUT THE ¿REMOTE ON AND ALL OF THOSE CAME ON.¿ IT WAS UNCLEAR WHAT THE PATIENT WAS REFERRING WHEN USING ¿IT.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN ¿DOCTORING¿ FOR A STROKE SINCE (B)(6) 2012. THE PATIENT HAD BEEN HELPED ONCE OR TWICE, BUT STILL HAD PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235707 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other