BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3132959 · Received May 29, 2013

    Report

    Report Number
    6000032-2013-00141
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 8, 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

    PRODUCT ID: 3888-28, LOT# L34679, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(6), IMPLANTED: (B)(6) 1995, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTED DEVICE ONLY LASTED 8 MONTHS. PLEASE REFER TO MANUFACTURES REPORT #S 6000032-2013-00139 AND # 6000032-2013-00140 FOR ADDITIONAL INFORMATION ON A RELATED DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED PREMATURE BATTERY DEPLETION. IT WAS THOUGHT THAT IT WAS DEFECTIVE, BUT WHEN THEY FOUND OUT SHE WAS RUNNING IT HIGH AND 24 HOURS A DAY, IT WAS DUE TO THE PATIENT DRAINING THE BATTERY BECAUSE OF USAGE. IT WAS NOTED THAT THE INS DIED (B)(6) 1999. THE RELEVANT MEDICAL HISTORY OF THE PATIENT INCLUDED FAILED BACK SURGERY SYNDROME AND ARACHNOIDITIS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236128 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