BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2770040 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08819
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 5, 2012
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), LOT # J0527137V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS DELIVERING THERAPY TO THE INCORRECT SIDE OF THE BODY. THE PATIENT HAD FALLEN SEVERAL TIMES "LATELY, 1-2 TIMES EVERY MONTH." AFTER EACH FALL THE HCP HAD REPROGRAMMED THE INS. PATIENT HAD JUST FALLEN AGAIN AND HER STIMULATION "MOVED FROM THE LEFT SIDE OF THE BODY TO THE RIGHT." PATIENT THOUGHT ... THE LEAD WIRE HAS MOVED A BIT," HOWEVER HCP HAS CHECKED THE LEAD AND "IT IS O.K." IT WAS REPORTED THE PATIENT HAS PAIN IN HER NECK FOR "THE LAST MONTH OR SO" AND IT IS, "NOT RIGHT." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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