BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2810032 · Received October 31, 2012

    Report

    Report Number
    3004209178-2012-09749
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 2, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V999673, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-28, LOT# V999673, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION. THE PATIENT REPORTEDLY FELT AN ACUTE PAIN DOWN THE LEFT SIDE OF THE BUTTOCK "FOLLOWING AN IMPLANT." IT WAS STATED THAT THE PATIENT'S STATUS WAS UNDETERMINED. IT WAS NOTED THAT THE PATIENT TURNED DOWN STIMULATION WHEN SHE FELT THE SHOCKING SENSATION, WHICH HELPED BUT THEN HER SYMPTOMS OF INCONTINENCE RETURNED. THE PATIENT REPORTEDLY DID NOT FEEL SHOCKING SENSATIONS ON PROGRAM 1, AND IT WAS INDICATED THAT THE DEVICE SOMEHOW HAD SWITCHED FROM THE ORIGINAL PROGRAM 1 TO PROGRAM 2. IT WAS LATER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE OR THERAPY, BUT WAS SCHEDULED TO WORK WITH HER DOCTOR OR MANUFACTURE REPRESENTATIVE ON (B)(6) 2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS STATED THAT THERE WERE NO ABNORMAL IMPEDANCES REPORTED. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND HAD NOT INJURY. IT WAS STATED THAT THE PATIENT HAD NOT CONTACTED THEIR HEALTH CARE PROVIDER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1