BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3172590 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10434
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3587A, LOT# L70168, IMPLANTED: (B)(6) 2000, PRODUCT TYPE LEAD; PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT ¿RECEIVED ASSISTANCE FROM THEIR DOCTOR AND THEIR CONCERNS WERE RESOLVED.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS DUE TO END OF LIFE. THE DEVICE WAS TO BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THOUGHT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DIED. IT WAS STATED THAT THE PATIENT STARTED TO TROUBLE WITH THE IMPLANT TURNING OFF AND HE WOULD TURN IT BACK ON, WHICH STARTED 2-3 MONTHS AGO. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273893 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR