BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3132391 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08220
    Event Type
    Malfunction
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# J0235468V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BLADDER DISCOMFORT. IT WAS NOTED THE OLD DEVICE HELPED WITH THE DISCOMFORT MORE. IT WAS REPORTED THE PATIENT HAD INTERSTITIAL CYSTITIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE HAD BEEN TURNING ITSELF ¿ON AND OFF¿ AT NIGHT. THE PATIENT STATED THAT IT WAS ¿NOT ALL THE TIME BUT IT WAS VERY DISCONCERTING.¿ THE PATIENT HAD TO GET UP TO TURN IT BACK ON AND WAS ¿NOT HAPPY¿ WITH HER NEW DEVICE. THE PATIENT LIKED THE OLDER DEVICE¿S PROGRAMMER BETTER AND IT ¿LASTED FOREVER.¿ THE PATIENT ALSO STATED THAT HER PROGRAMMER WAS ¿NOT WORKING¿ AND THAT WHEN SHE TRIED TO SYNC THE PROGRAMMER IT WENT BACK TO THE ¿FLASH SCREEN.¿ THE PATIENT HAD NOT DROPPED THE PROGRAMMER OR GOTTEN IT WET. 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
    236876 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1