BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4592029 · Received March 11, 2015

    Report

    Report Number
    3004209178-2015-04559
    Event Type
    Malfunction
    Date Received
    March 11, 2015
    Report Date
    December 24, 2014
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OVERSTIMULATION SENSATION. FROM THE TIME OF IMPLANT, UP UNTIL A COUPLE OF MONTHS AGO, THE PATIENT WOULD HAVE SUDDEN OVERSTIMULATION. THE BATTERY WOULD OVERSTIMULATE THE PATIENT AT TIMES. HOWEVER, THE ISSUE WAS REMEDIED BY A PROGRAMMING SESSION THAT OCCURRED A COUPLE OF MONTHS AGO WHERE THE MANUFACTURER'S REPRESENTATIVE CLEARED THE PREVIOUS PROGRAMMING, WHICH INCLUDED ADAPTIVE STIMULATION, AND RESET EVERYTHING WITH ADAPTIVE STIMULATION STILL IN PLACE. THE MANUFACTURER'S REPRESENTATIVE WAS ASKED IF THE OVERSTIMULATION WAS EXPECTED BASED ON THE PATIENT¿S PROGRAMMED ADAPTIVE STIMULATION. THE MANUFACTURER'S REPRESENTATIVE STATED IT WAS NOT RELATED TO ADAPTIVE STIMULATION. ALL THE IMPEDANCES LOOKED GOOD. THE ELECTRODE IMPEDANCES WERE IN THE 800-1190 RANGE AND THE MANUFACTURER'S REPRESENTATIVE HAD LOOKED AT MULTIPLE REFERENCES AND THERAPY IMPEDANCE. THE MANUFACTURER'S REPRESENTATIVE STATED SHE CHECKED ALL IMPEDANCES, CHECKED THE DEVICE CAREFULLY, AND THERE WAS NO ISSUE WITH THE STIMULATOR OR ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168727 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1