BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 3910426 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12465
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 11, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A-45, LOT # V759791, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # VA03QZD, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION. IT WAS REPORTED THAT 3 DAYS AGO THE STIMULATOR STOPPED WORKING. IT WAS STATED THAT THE PATIENT HAD TO GO TO THE EMERGENCY ROOM YESTERDAY BECAUSE OF THE PAIN AND THEY COULDN¿T DO ANYTHING ABOUT IT. IT WAS STATED THAT THE PATIENT PUT IT ON ¿FULL BLAST¿ (7V) AND STILL DIDN¿T FEEL ANYTHING. IT WAS NOTED THAT THE PATIENT WAS USUALLY AT 2V. IT WAS STATED THAT THE PATIENT TRIED DIFFERENT POSITIONS BUT IT DID NOTHING; THERE HAD BEEN NO FALLS OR TRAUMA. IT WAS STATED THAT YESTERDAY THE PATIENT HAD A STABBING SENSATION/PAIN ON THE RIGHT SIDE WHERE THE IMPLANT WAS ON THE TOP PORTION. IT WAS STATED THAT THE STABBING PAIN LASTED ¿FOR ABOUT THE MORNING¿. IT WAS STATED THAT IT WAS THERE IN THE MORNING AND WENT AWAY. IT WAS NOTED THAT THE PATIENT WAS NOT SURE IF IT WENT AWAY AFTER A SHOT ADMINISTERED AT THE ER OR ON ITS OWN. IT WAS NOTED THAT THE PATIENT NEEDED A NEW HEALTHCARE PROFESSIONAL (HCP) BECAUSE THE CURRENT HCP WOULDN¿T TAKE INSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388306 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR