BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2760703 · Received September 26, 2012

    Report

    Report Number
    6000032-2012-00151
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 27, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 2001-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3887-33, LOT# J0120839V, IMPLANTED: 2002-(B)(6), EXPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "MALFUNCTIONED" SPINAL CORD STIMULATOR WAS REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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