BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 3222516 · Received July 12, 2013

    Report

    Report Number
    6000032-2013-00170
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7424, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3487A, LOT# N22251, IMPLANTED: (B)(6) 1995: PRODUCT TYPE LEAD; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995: PRODUCT TYPE EXTENSION; PRODUCT ID 3487A, LOT# L35343, IMPLANTED: (B)(6) 1995: PRODUCT TYPE LEAD; PRODUCT ID 7495-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 1995: PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATOR WAS ¿COMING ON¿ INSIDE STORES AND AT HER MECHANIC. THE STIMULATION WAS PINCHING HER ON THE SIDE AND WHILE SHE SLEPT. THIS HAS BEEN HAPPENING FOR THE PAST 2 YEARS, AFTER SHE LOST ABOUT 75 POUNDS. THE PATIENT WAS ASSISTED TO TURN THE DEVICE OFF. IT WAS FURTHER REPORTED THAT THE PATIENT THOUGHT THE DEVICE MAY BE TURNING ON WHEN WALKING PAST LARGE MAGNETS. THE PATIENT PLANNED TO MEET WITH A PROVIDER TO HAVE THE DEVICE INTERROGATED. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT. OF NOTE, THE PATIENT HAD BILATERAL STIMULATORS. IT WAS UNKNOWN WHICH, OR IF BOTH, STIMULATORS WERE AFFECTED. SEE MFR # 6000032-2013-00169

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323006 ITREL II STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7424

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR