BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3173716 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10482
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 29, 2013
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ABOUT 4-5 WEEKS AGO THE PATIENT HAD RADIO FREQUENCY (RF) ABLATION AND SHE DID NOT TURN HER DEVICE OFF. THE PATIENT HAD PAIN NEAR HER SPINAL CORD STIMULATOR (SCS) SINCE IMPLANT BUT IT WAS NOTED IT HAD GOTTEN ¿WAY WORSE, FELT LIKE SOMEONE HAD STABBED HER IN THE STIMULATOR AREA¿ SINCE HER RF ABLATION PROCEDURE. IT WAS ALSO NOTED THE PATIENT HAD ALWAYS HAD DISCOMFORT. THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND ¿NEVER FELT LIKE HER DEVICE HAD DONE HER ANY GOOD SINCE HER FIRST SURGERY.¿ SHE HAD PREDNISONE SHORT EVERY 3 MONTHS AND NOW EVERY 2 MONTHS AND THEY WERE NOT HELPING HER. IT WAS NOTED AT NIGHT THE PATIENT THE PATIENT TURNED THE LEFT BUTTON DOWN TO 3 AND THE OTHER TO 10. 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
    273991 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 00077 YR