BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2950042 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01469
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    January 19, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 7434A, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3487MES, LOT# N23784, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN AND THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THERE WAS AN UNKNOWN INS ISSUE. THE PATIENT MET WITH A MANUFACTURER REPRESENTATIVE AND THE DEVICE WAS REPROGRAMMED ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF STIMULATION SENSATION AND THERAPEUTIC EFFECT. THE PATIENT REPORTED DANCING THE PREVIOUS NIGHT, BUT NOTHING UNUSUAL HAPPENED. SINCE THE PREVIOUS NIGHT THE PATIENT'S HEADACHE HAD RETURNED. IT WAS STATED THAT THE PATIENT USUALLY FEELS STIMULATION IF IT'S ON, BUT SHE WAS NOT FEELING ANYTHING EVEN WHEN SHE TRIED TO INCREASE STIMULATION. IT WAS NOTED THAT THE LIGHTS ON THE PROGRAMMER CONFIRMED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON AND THE BATTERY WAS "GOOD." ALL THE LIGHTS WERE GREEN. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54339 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