BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3023934 · Received March 27, 2013

    Report

    Report Number
    6000032-2013-00074
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 13, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748966, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: EXTENSION: PRODUCT ID 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3487A-33, LOT# J0333642V, IMPLANTED: (B)(6) 2003. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED IN 2003. THE PATIENT "HAD TO GO BACK" BECAUSE SHE WAS GETTING SHOCKED DUE TO FLUID IN THE POCKET. IT WAS REPORTED THAT THE PATIENT "HAD THAT FIXED." IT WAS UNCLEAR WHEN THIS EVENT OCCURRED. THIS EVENT WAS ALREADY REPORTED IN MFR. REP. # 6000032-2013-00069. ADDITIONAL REVIEW DETERMINED THAT THE SHOCKING INVOLVING FLUID IN THE POCKET AND THE SUBSEQUENT SHOCKING IN 2005 OR 2006 WERE SEPARATE EVENTS. ALL FUTURE FOLLOW-UP REGARDING THE SHOCKING DUE TO FLUID IN THE POCKET WILL BE REPORTED UNDER THIS MFR. REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126202 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