BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2833634 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10298
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 18, 2012
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377845, LOT#: V019019, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 377845, LOT#: V013156, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 37752, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER; PRODUCT ID: 37742, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) MAY HAVE "MOVED A LITTLE ONE WAY OR THE OTHER" FOLLOWING A FALL. IT WAS NOTED THAT THE PATIENT FELL WHEN THEY GOT OUT OF THE HOSPITAL. IT WAS BELIEVED THAT SOMETHING WAS "NOT RIGHT" WITH THE INS. THE PATIENT NOTED THAT IT WAS NOT WORKING RIGHT AND THEY COULD NOT GET IT TO CHARGE UP. IT WAS REPORTED THAT THE RECHARGER RUNS OUT OF "JUICE" AND COULD NOT FINISH RECHARGING THE BATTERY. IN ADDITION, IT WAS STATED THAT THE 2 DEVICES HAVE NEVER DONE WHAT THEY SAID THEY ARE GOING TO DO. THE PATIENT NOTED THAT THEY DID NOT KEEP THE RECHARGER UNIT PLUGGED. THE PATIENT WAS CONSIDERING HAVING THE INS TAKEN OUT. THE PATIENT WAS GOING TO GET SCHEDULED FOR A FOLLOW- UP VISIT WITH THE HEALTHCARE PROFESSIONAL AND THE COMPANY REPRESENTATIVE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1