BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 2895398 · Received January 3, 2013

    Report

    Report Number
    6000032-2013-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 12, 2012
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS ISCHEMIC PERIPHERAL PAIN. PRODUCT ID 7495, SERIAL# (B)(4), IMPLANTED: (B)(6) 1990, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A, LOT # L17856, IMPLANTED: (B)(6) 1990, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE FIRST BATTERY LASTED 9 MONTHS AND THEN IT WAS REPLACED. THEY BELIEVED THE DEVICE WAS REPLACED IN 1996 AND REPORTED THE BATTERY WAS DEAD AGAIN IN 9 MONTHS AND HAD NEVER BEEN CHANGED SINCE. THE DEVICE WAS IMPLANTED FOR THE PATIENT'S LEFT LEG AND FOOT AND THE LEG AND FOOT HAVE BEEN AMPUTATED FOR 15 YEARS. THE PATIENT HAD HAD CT SCANS DONE AND WAS TOLD "THEY DID NOT WANT TO DO AN MRI BECAUSE IT WOULD COOK THE ELECTRONICS INSIDE BUT IF IT WAS NO LONGER OPERATIVE AND THAT SHOULD NOT MATTER AND THAT THE PATIENT COULD PROBABLY HAVE AN MRI." IT WAS ALSO NOTED THEY WERE TOLD BY A TECHNICIAN "THE MRI WOULD NOT PULL IT OUT OF THEIR BODY LIKE THEY HAD BEEN TOLD." IT WAS NOTED THE PATIENT THOUGHT "PART OF THEIR MEDICAL PROBLEMS COULD BE ASSOCIATED WITH THE IMPLANT DETERIORATING AS WELL AS PART OF THEIR UNBEARABLE BACK PAIN." PATIENT WAS CONCERNED WITH HAVING DEVICE REMOVED AND WOULD LIKE TO BE ABLE TO HAVE AN MRI. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3713 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