BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3052707 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06005
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V312713, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V285772, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WAS CUT DURING A PLASTIC SURGERY PROCEDURE. IT WAS REPORTED FOUR DAYS LATER THAT NOTHING WAS BELIEVED TO BE EXPLANTED. THE PATIENT WAS INFORMED TO GO BACK TO HER IMPLANTING HEALTH CARE PROVIDER (HCP). ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURING REPORT #3004209178-2013-06002. IT WAS UNKNOWN WHICH LEAD WAS CUT AND THUS BOTH ASSOCIATED IMPLANTS WERE REPORTED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155462 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1