BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3116722 · Received May 16, 2013

    Report

    Report Number
    3004209178-2013-07786
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# V896802, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF BLADDER CONTROL WHICH BEGAN "ABOUT TEN DAYS TO TWO WEEKS" PRIOR TO THE REPORT. THE PATIENT WAS URINATING "EVERY HALF HOUR TO HOUR." THE PATIENT WAS ON PROGRAM 1 AT 3.9 VOLTS BUT DID NOT SEE THE "LIGHTNING BOLT." THE PATIENT WAS ASSISTED IN TURNING STIMULATION ON AND IT WAS "A LITTLE TOO MUCH." THE PATIENT TURNED DOWN STIMULATION TO 3.5 VOLTS AND IT WAS COMFORTABLE. ABOUT TWO WEEKS LATER IT WAS REPORTED THAT BESIDES THE PATIENT'S EARLIER ISSUE OF THE DEVICE BEING OFF, A URINARY TRACT INFECTION (UTI) WAS FOUND ON THE DAY OF THE REPORT. THE PATIENT WAS GIVEN ANTIBIOTICS AND HOSPITALIZATION WAS NOT REQUIRED. THE PATIENT OUTCOME WAS NOTED AS NON-SERIOUS INJURY OR ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218037 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention