BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3203840 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11243
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 11, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT # V013727, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT IMPEDANCE CHECK SHOWED NUMBERS THAT WERE ¿TOO HIGH¿. THE REVISION WAS COMPLETED TWO DAYS AFTER THE ISSUE BEGAN. IT WAS DETERMINED IN THE OPERATING ROOM THAT THE LEAD HAD BEEN PLACED IN S4, NOT S3. AS SUCH, A NEW LEAD WAS IMPLANTED AND THE BATTERY WAS REPLACED. THE PATIENT WAS REPORTEDLY DOING ¿VERY WELL¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE ¿SHOCKED¿ HER. AN IMPEDANCE CHECK SHOWED ¿ISSUES¿ WITH THE DEVICE. THE PATIENT HAD CHEST PAIN AND COMPLAINED OF SHORTNESS OF BREATH. THE HEALTH CARE PROVIDER (HCP) PLANNED ON DOING A REVISION. ABOUT TWO WEEKS LATER IT WAS REPORTED ON (B)(6) 2013 THAT THE STIMULATION WAS ON 5.9 VOLTS AND THE PATIENT WAS NOT FEELING STIMULATION. THEN ALL OF THE SUDDEN THE DEVICE ¿SHOCKED¿ THE PATIENT IN THE VAGINAL AREA AND SHE ¿JUMPED OUT OF HER CHAIR.¿ THE PATIENT WAS TOLD THAT THE LEAD WAS NOT ¿MAKING ANY CONTACT ON ITS OWN¿ AND THAT ¿EVERYTHING¿ NEEDED TO BE REPLACED. THE PATIENT WAS TOLD BACK IN FEBRUARY THAT THE ¿ENTIRE THING¿ NEEDED TO BE REPLACED BUT GOT AN X-RAY AT THAT TIME. IT WAS THOUGHT AT THAT TIME ONLY THE BATTERY NEEDED TO BE REPLACED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT IT WAS PREVIOUSLY REPORTED IN (B)(6) 2012 THAT THE PATIENT¿S INTERNAL BATTERY WASN¿T WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305484 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention