BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3082159 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-06989
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-28, LOT# L69154, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: LEAD: PRODUCT ID 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999. PRODUCT TYPE: EXTENSION: PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ELECTROCARDIOGRAM (EKG) A WEEKS AGO, IN WHICH THE PATIENT TURNED THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF. AFTER APPROXIMATELY 2 HOURS, THE PATIENT TRIED TO TURN THE INS BACK ON, BUT WAS UNSUCCESSFUL. IT WAS STATED THAT THE PATIENT TRIED PUTTING NEW BATTERIES IN THE PATIENT PROGRAMMER. IT WAS FURTHER STATED THAT THE ONLY STATUS LIGHT ON THE BACK OF THE PATIENT PROGRAMMER WAS FOR THE PATIENT PROGRAMMER BATTERY, WITH NO STATUS LIGHTS FOR THE INS. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH HER MANAGING PHYSICIAN ON (B)(6) 2013. THE PHYSICIAN TOLD THE PATIENT TO CONTACT THE MANUFACTURER REPRESENTATIVE. THE PATIENT WAS UNABLE TO CONTACT THE MANUFACTURER REPRESENTATIVE DUE TO AN INCORRECT NUMBER. THE PATIENT WAS INSTRUCTED TO SCHEDULE AN APPOINTMENT WITH THE PHYSICIAN AND INVITE THE LOCAL REPRESENTATIVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT DURING THE EKG, A PROBLEM OCCURRED. THE PATIENT STATED ¿I SHUT IT OFF BECAUSE THEY WERE DOING AN EKG ON ME AND IT WAS MAKING THE MACHINE FLUTTER SO I SHUT IT OFF.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185500 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 00067 YR