BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1770235 · Received July 21, 2010

    Report

    Report Number
    6000032-2010-05628
    Event Type
    Injury
    Date Received
    July 21, 2010
    Report Date
    June 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = URINARY PROBLEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE PROBLEMS REGARDING STIMULATION AND EFFECTS OF AN MRI ON THE IMPLANTABLE NEURO STIMULATOR (INS). PATIENT STATED THAT "STIMULATION WAS TURNING OFF". HOWEVER, PATIENT ALSO STATED THAT "INS BATTERY IS DEAD AND HE HAS NOT BEEN USING STIM FOR QUITE SOME TIME". HCP INDICATED, HE COULD HAVE AN MRI PERFORMED. DURING THE MRI, PATIENT STATED, HE EXPERIENCED A "SHOCKING OR JOLTING SENSATION". PATIENT STATED DURING THE SCAN HE "YELLED AT TECH THREE TIMES" THAT HE WAS EXPERIENCING PAIN AND REQUESTED FOR THE SCAN TO BE STOPPED. SCAN WAS NOT STOPPED. DURING/FOLLOWING AN MRI, PATIENT REPORTED PAIN IN THE MIDDLE OF HIS BACK, AROUND LEADS, URINARY PROBLEMS, AND WEAKNESS IN LEGS. PATIENT STATUS WAS LISTED AS FAIR. ANY ADDITIONAL INFORMATION WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| LEAD: MODEL 3487A, LOT#J0120567V| IMPLANTED:| EXTENSION: MODEL 7495-25, LOT#NAF020251N| PROGRAMMER: MODEL 7434A, LOT#NGL003255P| EXPLANTED:| IMPLANTED: