BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2880071 · Received December 19, 2012

    Report

    Report Number
    3004209178-2012-12049
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Report Date
    November 27, 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
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V534780, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT. PATIENT SYMPTOMS RETURNED STARTING IN THE BEGINNING OF (B)(6) 2012. SYMPTOMS INCLUDED 'LEAKING AND GOING TO THE BATHROOM A LOT AND FREQUENTLY.' IT WAS NOTED THE PATIENT HAD PEED IN THE BED PRIOR TO AN APPOINTMENT WITH THEIR HEALTH CARE PROVIDER. PATIENT'S MEDICATION WAS INCREASED. IT WAS ALSO REPORTED THE PATIENT HAD PAIN IN THE LEFT BUTTOCKS AND THAT THEY HAD BEEN TRYING TO INCREASE STIMULATION WHICH HELPED THE PAIN, BUT MADE THE PATIENT GO TO THE BATHROOM MORE OFTEN. IT WAS ALSO REPORTED THE PATIENT'S 'MACHINE WAS TURNING ITSELF OFF.' IT WAS CONFIRMED THE DEVICE WAS ON AT THE TIME OF REPORT. IT WAS NOTED THE PATIENT STATED 'THE PROBLEM HAD BEEN FIXED.' PATIENT WAS ON PROGRAM 4 AT 2.4 VOLTS. FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS NOTED THERE WAS A REVISION IN (B)(6) 2012. AFTER REVISION THE PATIENT HAD PAIN IN THEIR LEFT BUTTOCK AREA, DEVICE WAS IMPLANTED ON THE RIGHT. PAIN RESOLVED AFTER TURNING THE DEVICE OFF. GRADUALLY THEY HAD BEEN ADJUSTING PROGRAMMING. PATIENT INCONTINENCE RETURNED WHEN THE DEVICE WAS TURNED OFF. THE PATIENT SYMPTOMS WERE SLOWLY RESOLVING AND THE PATIENT HAD NO PAIN IN THEIR LEFT GLUTEAL AREA AT THE TIME. REFER TO MANUFACTURER REPORT # 3004209178-2012-11920 FOR REPORT ON REVISION OF DEVICE.

    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