BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3211125 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11451
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA03GDQ, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENTS CONCERNS RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FELT URGENCIES THE ¿LAST COUPLE DAYS.¿ THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND HAD BEEN GOING TO THE BATHROOM A LOT. THE PATIENT THOUGHT IT WAS BECAUSE SHE HAD BEEN ¿A LITTLE UPSET AND WOULD GO AWAY,¿ BUT IT HAD NOT IMPROVED. THE PATIENT TRIED INCREASING STIMULATION ON PROGRAM 3 THE ¿OTHER DAY AND YESTERDAY¿ BUT DID NOT SEE AN IMPROVEMENT SO PUT IT BACK. THE PATIENT FELT STIMULATION BUT HER SYMPTOMS WERE NOT IMPROVING. THE PATIENT WAS ASSISTED WITH SWITCHING PROGRAMS. THE PATIENT SWITCHED TO PROGRAM 4 AND ADJUSTED TO 0.7 VOLTS WHERE SHE FELT STIMULATION COMFORTABLY IN THE BICYCLE SEAT AREA. EIGHT DAYS LATER IT WAS REPORTED THAT THE PATIENT WAS STILL FEELING ¿A LOT OF PRESSURE¿ AND EXPERIENCING FREQUENCY. THE PATIENT CONTACTED HER HEALTH CARE PROVIDER (HCP) THE MORNING OF THE REPORT AND ALSO SAW THE HCP ON (B)(6) 2013. THE PATIENT WENT IN TO BE CHECKED FOR A URINARY TRACT INFECTION (UTI) AND WAS TOLD BY THE HCP THAT ¿THEY SAW SOMETHING¿ SO WAS GIVEN ANTIBIOTICS. HOWEVER, THE PATIENT¿S SYMPTOMS HAD NOT YET IMPROVED AND SHE WAS DIRECTED BY THE HCP TO SWITCH PROGRAMS. THE PATIENT WAS ASSISTED IN ADJUSTING BACK TO PROGRAM 3 FROM 4. THE SETTING WAS AT 1 VOLT AND THE PATIENT BARELY FELT STIMULATION SO SHE INCREASED ¿A LITTLE.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311283 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention