BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3103187 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01572
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 12, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1997, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-28, LOT# L46768, IMPLANTED: (B)(6) 1997, PRODUCT TYPE LEAD; PRODUCT ID 3888-28, LOT# L44897, IMPLANTED: (B)(6) 1997, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN A CAR ACCIDENT ABOUT 16 TO 17 YEARS PRIOR TO THIS REPORT AND WAS SHOCKED AS THE LEADS WERE MOVED FROM THEIR SET POSITION. IT WAS ADDED THAT A REVISION WAS DONE AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203252 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