BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2799678 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09351
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    September 21, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V913913, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# 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 LOSS OF THERAPEUTIC EFFECT. THERAPY WORKED FOR ABOUT 2 1/2 WEEKS AND THEN THE PATIENT WENT ON VACATION FOR 10 DAYS AND IT DIDN'T. THE PATIENT WENT TO THE DOCTOR'S YESTERDAY AND HE WORKED WITH IT, BUT MUST HAVE LEFT IT OFF BECAUSE STIMULATION WAS NOT ON TODAY. THE PATIENT'S WIFE TURNED IT ON, IT WAS ON P1, AND THE PATIENT COULD FEEL IT BUT NOT QUITE THE SAME WAY. IT WAS SWITCHED TO P2 AND THE PATIENT COULD FEEL IT COMFORTABLY AT 3.4V AND REPORTED THAT IT FELT SIMILAR TO THE FIRST COUPLE OF WEEKS. IT WILL BE LEFT ON P2 AND THE PATIENT WOULD MONITOR SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN BY HIS HEALTH CARE PROVIDER (HCP) ON (B)(6) 2012. THE PATIENT WAS AT 3.5V ON EACH OF THE 4 PROGRAMS AND COULD NOT GET A POSITIVE SENSATION OF STIMULATION. THE STIMULATOR WAS REPROGRAMMED AND THE AMPLITUDE LIMIT WAS RESET. IT WAS STATED THAT THE STIMULATION SENSATION WAS NEAR HIS SCROTUM ON EACH OF THE 4 PROGRAMS. LATER IT WAS REPORTED THAT THE PATIENT WAS RECEIVING APPROPRIATE STIMULATION. IT WAS NOT POSSIBLE TO DETERMINE IF THERAPY WAS EFFECTIVE AT THAT TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD CONCERNS WITH HIS DEVICE OR THERAPY. IT WAS STATED THAT THE PATIENT DID NOT RECEIVE HELP FROM HIS DOCTOR DUE TO THE DOCTOR NOT BEING UNFAMILIAR WITH THE PROGRAMMING OF THE DEVICE. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2012. IT WAS NOTED THAT THE PATIENT COULD NOT REACH THE MANUFACTURER REPRESENTATIVE. SUBSEQUENT INFORMATION RECEIVED 10 DAYS LATER REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS. THE REPORTER STATED THAT HE "COULD NOT CONTROL HIS BLADDER." THE PATIENT REPORTED GOING TO BATHROOM MORE OFTEN AND WETTING BEFORE GETTING TO THE BATHROOM. IT WAS NOTED THAT THE PATIENT HAS TRIED ALL FOUR PROGRAMS AND THE PATIENT WAS CURRENTLY ON PROGRAM 1 AT AMPLITUDE 3.5 VOLTS. THE PATIENT CHANGED SETTINGS TO PROGRAM 2 AT AMPLITUDE 3.5 VOLTS (UPPER LIMIT). ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    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