BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3811354 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08991
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 23, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THE PATIENT WAS SITTING ON THE PORCH ON THE DAY PRIOR TO THE REPORT AND FELT A SHOCK FROM THE BATTERY PACK IN HER CHEST, RIGHT SIDE, DOWN TO HER ABDOMEN. THE PATIENT STATED IT REALLY HURT AND HAD NEVER FELT IT BEFORE. IT WAS NOTED THE PATIENT HAD NO FALLS, TRAUMA, AND HAD NOT BEEN STRETCHING/BENDING/BOUNCING. THE PATIENT STATED THAT SHE ¿WONDERED IF IT HAD HAPPENED BEFORE OR IF IT WAS STRANGE OR WHAT?¿ IT WAS NOTED THAT THE PATIENT¿S SYSTEM WAS FOR MIGRAINES AND THE BATTERY PACKS WERE IN THE CHEST AND THE WIRES WENT UP TO THE NECK AND AROUND THE FOREHEAD AND BACK OF THE HEAD. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THE DEVICE OR THERAPY BUT WAS WORKING WITH THE HEALTH CARE PROFESSIONAL OR MANUFACTURING REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT DATE OF (B)(6) 2014. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290778 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 00039 YR