BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3023438 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04298
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7434, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7434-E, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 3887-33, LOT # J0019934V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS STATED THE DEVICE WAS "ZAPPING HER" SINCE (B)(6) 2013, AND WAS "HURTING HER WHOLE BODY." THE PATIENT CANNOT FIND HER PROGRAMMER TO TURN THE STIMULATION DOWN OR OFF. IT WAS NOTED THE PATIENT FELL ON THE SIDE OF HER IMPLANT "RECENTLY", PRIOR TO (B)(6) 2013. THE PATIENT STATED SHE DID NOT HAVE A FOLLOWING PROVIDER AT THE TIME OF THIS CALL. THE PATIENT WAS REDIRECTED TO HER "OLD" HEALTH CARE PROVIDER. A LIST OF LOCAL PROVIDERS WERE ALSO PROVIDED TO THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126755 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1