BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2843889 · Received November 23, 2012

    Report

    Report Number
    3004209178-2012-10712
    Event Type
    Injury
    Date Received
    November 23, 2012
    Report Date
    October 26, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V318137, IMPLANTED: 2009 (B)(6), EXPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A TOTAL DEVICE SYSTEM REMOVAL. IT WAS NOTED THAT 3 MONTHS AFTER THE INITIAL IMPLANT, THE DEVICE WAS "ALMOST OUT OF HER SKIN" AND THAT THE PATIENT COULD "REACH BACK THERE AND TAKE THE DEVICE." IT WAS STATED THAT THE DEVICE WAS REPROGRAMMED "SEVERAL" TIMES AND THAT THE PATIENT FELT "ELECTRIC SHOCKING" THROUGHOUT HER BODY. IT WAS FURTHER REPORTED THAT THE PATIENT HAD PROBLEMS WITH "AWFUL SHOCK FEELING SENSATIONS." IT WAS STATED THAT THE DEVICE "WORKED ITS WAY OUT" OF THE PATIENT'S SKIN "WITHIN 1.5 MONTHS." IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVES TRIED "3 OR 4 TIMES" TO TRY TO GET THE DEVICE "IN SYNC." IT WAS INDICATED THAT THE PROBLEM WAS THAT THE DOCTOR DID NOT IMPLANT "FAR ENOUGH DOWN." IT WAS STATED THAT THE PATIENT CHOSE NOT TO HAVE THE DEVICE REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    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 Required Intervention