BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3890431 · Received June 24, 2014

    Report

    Report Number
    6000032-2014-00125
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 3, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3887-33, LOT# L66644, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) USED TO INCREASE IN VOLTAGE ON ITS OWN AND, SINCE, HAD THE DEVICE REPLACED. IT WAS NOTED THAT THIS HAPPENED 5 YEARS AGO. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367776 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 00045 YR Required Intervention