BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3057793 · Received April 15, 2013

    Report

    Report Number
    3004209178-2013-06231
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    March 22, 2008
    Report Date
    September 25, 2020
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT# V062321, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPEDANCE CHECK REVEALED THAT IMPEDANCES WERE 'RUNNING HIGH.' NO SPECIFIC NUMBERS WERE GIVEN. THE PATIENT HAD 2 ELECTRODES PREVIOUSLY TURNED OFF, AND ANOTHER ONE AFTER THE LATEST IMPEDANCE CHECK WAS TURNED OFF. THE PATIENT STATED THAT WHEN IMPEDANCE LEVELS WERE HIGH, IT FELT AS IF AN ELECTRODE HAD TO BE TURNED OFF. IT WAS ALSO STATED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION AFTER REPLACING THE PATIENT PROGRAMMER BATTERIES. THE STIMULATION FELT STRONGER TO THE PATIENT AFTER CHANGING BATTERIES AND THEY WERE NOT ABLE TO HANDLE THE SAME LEVEL OF STIMULATION AS BEFORE. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD ¿TO GO LOWER BECAUSE IT¿S IN MY NECK¿ .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161163 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR "SEE H10...."