BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2994281 · Received March 8, 2013

    Report

    Report Number
    6000032-2013-00057
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 20, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # (B)(4), IMPLANTED: (B)(6) 1997, EXPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL # (B)(4), IMPLANTED: (B)(6) 1997, EXPLANTED: (B)(6) 1999, PRODUCT TYPE EXTENSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A LOT OF PAIN WITH THE IMPLANTABLE NEUROSTIMUATOR AND DID NOT GET ANY RELIEF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS "FINALLY" NOT GETTING THE RELIEF FROM A DEVICE "THAT WAS NECESSARY." THE DEVICE WAS REMOVED AND THE PATIENT USED A DIFFERENT PAIN MANAGEMENT THERAPY. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98558 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 Required Intervention