BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3790741 · Received May 5, 2014

    Report

    Report Number
    6000032-2014-00090
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    March 7, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3587A, LOT# L47737, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3587A, LOT# L47737, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ABANDONED LEAD AND AN EXTENSION THAT WAS CUT TO REMOVE THE BATTERY. IT WAS UNKNOWN WHEN THE BATTERY WAS REMOVED, BUT IT WAS INDICATED IT WAS REMOVED BECAUSE IT WASN'T GIVING STIMULATION IN LEGS WHERE THE PATIENT NEEDED IT. THE PATIENT THEN UNDERWENT A TRIAL FOR THE CURRENT SPINAL CORD STIMULATION (SCS) SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267557 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 Other| R