BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2676530 · Received July 31, 2012

    Report

    Report Number
    3004209178-2012-06317
    Event Type
    Injury
    Date Received
    July 31, 2012
    Report Date
    July 3, 2012
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, LOT# V132935, SERIAL#, IMPLANTED: 2008 (B)(6), EXPLANTED: PRODUCT TYPE LEAD, PRODUCT ID 3037, LOT#, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING ACUTE PAIN. TWO DAYS AGO THE PATIENT HAD BACK PAIN ((B)(6) 2012) AND FREQUENT URINATION ((B)(6) 2012). THE PATIENT WAS DIAGNOSED WITH AN UTI (URINARY TRACT INFECTION) ON (B)(6) 2012. THE PATIENT WAS AT THE DOCTOR'S OFFICE APPROXIMATELY SIX MONTHS AGO. SHE WAS ABLE TO STRENGTHEN HER STIMULATION SENSATION A LITTLE. THE PATIENT HAS HAD THE DEVICE FOR FOUR YEARS AND THE DOCTOR'S OFFICE TOLD HER IT WOULD LAST ANOTHER TWO YEARS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S BACK PAIN WAS CUT IN HALF WHEN SHE GOT THE DEVICE IMPLANTED. SHE WAS IMPLANTED FOR LEAKAGE, AND IT ALSO HELPED WITH HER BLADDER. THE PATIENT WAS LEAKING REALLY BADLY, GOING THROUGH 6 TO 7 PADS PER DAY; SHE WAS PREVIOUSLY GOING THROUGH 3 PADS PER DAY. THE PATIENT'S BACK HAS "BEEN WORKING," AND THROUGH THE NIGHT, SHE WAS NOT FEELING STIMULATION. THE PATIENT STATED THAT STARTING MONDAY SHE STOPPED FEELING STIMULATION. FURTHER INFORMATION RECEIVED REPORTED THAT THE PATIENT MET WITH HER DOCTOR ON (B)(6) 2012 AND HER CONCERNS WERE RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention