BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2840766 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10584
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 24, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S LEAD HAS "SLIPPED DOWN" FROM BEING ANCHORED AT T10 TO T11/T12. PATIENT HAS HAD NO RELIEF. REPROGRAMMING WAS ATTEMPTED BUT WAS NOT SUCCESSFUL. X-RAYS WERE TAKEN AND CONFIRMED THE LEAD SLIPPED THOUGH THEY DID NOT CONFIRM HOW IT OCCURRED. PATIENT EXPERIENCED PAIN IN KNEE TO GROIN AREA, "IT IS STIFF." PATIENT ALSO SUFFERED FROM SPINAL STENOSIS. PATIENT HAD SUCCESS WITH TRIAL FOR SHINGLE PAIN INITIALLY, BUT PATIENT'S PAIN IS CURRENTLY MOVING UP THEIR SIDE. FOLLOW UP REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR MEDTRONIC REPRESENTATIVE. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO FINDINGS OR ISSUES. THE PATIENT OUTCOME WAS UNKNOWN. NO MEDICAL INTERVENTION HAD BEEN SCHEDULED AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1