BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4123276 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17841
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 6, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT'S PHYSICIAN HAD NO FURTHER INFORMATION, AS THE PATIENT HAD NOT BEEN SEEN FOR AT LEAST 1 YEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SHOCKING OR JOLTING SENSATION. THE DEVICE WAS SHOCKING HIM RANDOMLY, SOMETIMES ONCE A DAY OR SOMETIMES TWENTY TIMES A DAY. THE DEVICE HAD BEEN OFF FOR ABOUT A YEAR BECAUSE IT GOT TO WHERE HE COULDN¿T ADJUST IT AWAY. THEY PROGRAMMED IT ONCE AND IT WORKED FOR TWO WEEKS AND AFTER THAT THEY SAID THEY COULDN¿T ADJUST IT ANY MORE. IT WAS NOTED THAT THE PATIENT WANTED TO USE AN ¿ICY/HOT¿ TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602480 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1