BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3251697 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12399
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 2, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3587A, LOT# N101105, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 748966, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT FELL OFTEN AND THE LAST "BAD FALL" WAS REPORTEDLY 2 MONTHS PRIOR TO THE REPORT WHEN THE PATIENT FELL ONTO THE BACKSIDE. THE REPORTER INDICATED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. THE JOLTING WAS IN THE LOWER BACK AND BUTTOCK AND WAS HAPPENING WHEN STIMULATION WAS BEING TURNED UP TO THRESHOLD OR WHEN THE PATIENT LAY DOWN. PARASTHESIA WAS TO BE IN THE LEG. THE REPORTER ALSO NOTED THAT THE IMPEDANCE READINGS WERE GREATER THAN 4000 OHMS ON SOME BIPOLAR PAIRS AS WELL AS ON ALL OR SOME UNIPOLAR PAIRS. THE PATIENT WAS "VERY SENSITIVE" SO THE TEST WAS INITIALLY DONE AT 0.25V BUT THE REPORTER RE-RAN THE TEST AT 0.75V AND WAS ABLE TO PRODUCE NORMAL IMPEDANCE VALUES. IT WAS FURTHER REPORTED THAT NO MALFUNCTIONS WERE SEEN AND NO CAUSE OF THE EVENT WAS DETERMINED. IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL DID NOT ORDER ANY FURTHER TESTING AND NO INTERVENTIONS WERE TAKEN OR PLANNED. THE PATIENT'S "PAIN PATTERN" HAD CHANGED AND HE REQUIRED ADDITIONAL COVERAGE THAN WHAT THE STIMULATOR WAS ORIGINALLY PUT IN FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352355 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 00043 YR