BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2900432 · Received January 7, 2013

    Report

    Report Number
    3004209178-2013-00274
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377760, LOT# V006158, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED, THE PATIENT MET WITH THEIR DOCTOR ON (B)(6) 2012. IT WAS STATED, THE INS WAS NO LONGER FUNCTIONAL "PROBABLY DUE TO CHARGING ISSUES". IT WAS ALSO STATED, THE PATIENT HAD ONGOING BACK AND LEG PAIN AND NECK AND ARM PAIN. A PADDLE LEAD PLACEMENT WAS DISCUSSED. IT WAS STATED, THE PATIENT HAD OTHERWISE REMAINED STABLE. SIMPLE EVALUATION AND ASSESSMENT REPROGRAMMING OF THE INS WAS DONE. IT WAS DETERMINED THAT THE INS WAS NO LONGER ABLE TO BE ACTIVATED. THE PATIENT WAS ALSO SEEN ON (B)(6) 2013 AND IT WAS STATED, THE INS WAS "CLEARLY DEAD". THE PATIENT WAS CLEAR THAT WHEN THE "STIMULATION WAS WORKING, IT CONTROLLED THE PAIN IN THE BACK AND LEFT LEG AND ALSO IN THE RIGHT LEG". HER INS HAD BEEN NON-FUNCTIONAL FOR QUITE SOME TIME. FOLLOW UP WAS PLANNED FOR ONE MONTH TO DISCUSS INS REMOVAL AND REPLACEMENT OF TWO LEADS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY AND WAS WORKING WITH HER HEALTHCARE PROFESSIONAL OR MANUFACTURER REPRESENTATIVE. NO APPOINTMENT DATES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH SYMPTOMS OF "INCREASED BASELINE" PAIN IN HER LEGS AND BACK. THE REPORTER STATED THAT THE DEVICE HADN'T WORKED FOR "A LONG TIME" BUT THERE WAS NO KNOWN ACCIDENT RELATED TO THE COMPLAINT. AN ATTEMPT HAD BEEN MADE PREVIOUSLY TO TRY TO REPLACE IT BUT THE PATIENT WASN'T ABLE TO AT THE TIME. HOWEVER, THE PATIENT'S CONDITION HAD "WORSENED" AND SHE WANTED TO SCHEDULE A REPLACEMENT. IT WAS NOTED THAT "EXTRA LEADS" WERE GOING TO BE IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7019 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention