BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2822458 · Received November 7, 2012

    Report

    Report Number
    3007566237-2012-02636
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS IN OVERDISCHARGE AND THE PATIENT HAD A LOSS OF PAIN RELIEF. IT WAS THOUGHT THAT THE OVERDISCHARGE WAS DUE TO IMPLANT DEPTH BUT THE IMPLANTING PHYSICIAN DISAGREED STATING THAT "IT COULD BE A COMBINATION OF THIS AND PATIENT NON-COMPLIANCE." THE PATIENT WAS SEEN IN CLINIC AND THE DEVICE WAS UNABLE TO BE RECHARGED. THE PATIENT THEN WAS SEEN BY THEIR HEALTH CARE PROVIDER (HCP) AND A MANUFACTURE REPRESENTATIVE AND THEY WERE UNABLE TO INTERROGATE THE DEVICE OR COMMUNICATE WITH THE DEVICE USING THE RECHARGER. THE DEVICE WAS REPORTEDLY DIFFICULT TO FEEL AS THE PATIENT WAS "QUITE LARGE." THIS SUGGESTED THAT THE DEVICE WAS IMPLANTED TOO DEEP. COUPLING WAS CHECKED AND SAID APPROXIMATELY 50. TROUBLE SHOOTING WAS CONDUCTED AND A BATTERY RESET WAS PERFORMED. IT WAS LATTER REPORTED THAT THE HCP WAS STILL UNABLE TO COMMUNICATE WITH OR RECHARGE THE DEVICE AFTER THE RESET. A WEEK LATER IT WAS REPORTED THAT ANOTHER PHYSICIAN RESTART WAS ATTEMPTED ON THE BATTERY AND WAS AGAIN UNSUCCESSFUL. THE PATIENT WAS REVISED ON (B)(6) 2012. THE BATTERY WAS APPROXIMATELY 2 CENTIMETERS DEEP IN THE ABDOMEN. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED UNDER STERILE CONDITIONS AND A PHYSICIAN RESTART WAS DONE AND WAS SUCCESSFUL. THE DEVICE WAS THEN PLACED BACK INTO THE POCKET BUT IN A MORE SUPERFICIAL POSITION. AFTER THE OPERATION THE PATIENT WAS SEEN AND THE DEVICE WAS SET ON CHARGE.

    Description of Event or Problem · 1

    IT WAS CLARIFIED THAT THE PATIENT HAS NOT HAD STIMULATION SINCE AUGUST. SHE HAD QUITE A FEW FALLS AND AFTER A FALL IT STOPPED WORKING COMPLETELY. SHE THEN STOPPED CHARGING THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention