BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3093182 · Received May 4, 2013

    Report

    Report Number
    3004209178-2013-07317
    Event Type
    Malfunction
    Date Received
    May 4, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN: PRODUCT ID 3093-28, LOT# V744240, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS UNABLE TO BE ADJUSTED. A "CALL YOUR DOCTOR" ICON WAS REPORTED. A POWER ON RESET (POR) CONDITION WAS REPORTED AS WELL. THE POR MESSAGE WAS NOTICED DURING RECOVERY FROM A REVISION SURGERY THE PREVIOUS DAY. (REFER TO MANUFACTURER REPORT #3004209178-2013-07316.) NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195811 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1