BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1123869 · Received August 15, 2008

    Report

    Report Number
    6000032-2008-05000
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MDT PUERTO RICO OPERAITONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEADS BURNT.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LACK OF EFFECT IN HER AREA OF PARESTHESIA FOLLOWING A MAGNETIC RESONANCE IMAGING OF THE PATIENT'S HEAD. IT WAS REPORTED THAT THE LEADS HAD BEEN BURNT AND NEEDED TO BE REPLACED. THE HCP INDICATED THERE WAS NO INJURY AND TISSUE DAMAGE ASSOCIATED WITH THE MAGNETIC RESONANCE IMAGING. THE HCP REQUESTED AN X-RAY OF THE THORACIC AND LUMBAR SPINE (RESULTS NOT REPORTED). THE MANUFACTURER'S FIELD REPRESENTATIVE CHECKED THE DEVICE AND IT WAS DETERMINED THAT THE NEUROSTIMULATOR BATTERY WAS VERY LOW AND LATER DEPLETED. DEVICE REGISTRATION SYSTEM INDICATES THE DEVICE SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MDT PUERTO RICO OPERAITONS CO, MED REL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3587A| EXPLANTED:| EXTENSION: MODEL 7495-25| IMPLANTED:| PROGRAMMER: MODEL 7434A