BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2880367 · Received December 19, 2012

    Report

    Report Number
    6000032-2012-00228
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A, LOT# J0015980V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD UNDERGONE A REVISION TO ADD A SECOND LEAD FOR BETTER COVERAGE. IT WAS FOUND THAT THE OLDER LEAD WAS NOT PLACED RIGHT AND WAS PROVIDING POSITIONAL COVERAGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO, MED REL 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention