BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3082703 · Received April 29, 2013

    Report

    Report Number
    6000032-2013-00107
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    May 15, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3487A, LOT# L50869, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IMPLANT SITE FOR 3-4 MONTHS PRIOR TO THE REPORT. IT WAS ALSO NOTE THAT STIMULATION WOULD COME ON WITHOUT THE REMOTE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185892 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