BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3261891 · Received August 2, 2013

    Report

    Report Number
    3004209178-2013-12694
    Event Type
    Injury
    Date Received
    August 2, 2013
    Date of Event
    July 6, 2013
    Report Date
    July 8, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 3708340 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3998 LOT# V113343, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37083-40 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON 2013 (B)(6), THERE WAS NO COMMUNICATION WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) FROM EITHER THE RECHARGER OR PATIENT PROGRAMMER. IT WAS STATED, THE RECHARGER HAD A REPOSITION RECHARGER ANTENNA SCREEN WITH RECHARGER ICON. AN INS OVERDISCHARGE WAS SUSPECTED. REPORTEDLY, THE LAST SUCCESSFUL RECHARGING SESSION WAS ABOUT TWO TO THREE WEEKS PRIOR TO REPORT. IT WAS STATED, THE PATIENT EXPERIENCED ¿SERIOUS PAIN AND COULDN¿T MOVE¿ AND THIS WAS NEW PAIN. IT WAS NOTED, THE PAIN WAS COMING FROM THE ¿TOP OF A LEAD,¿ IN THE MIDDLE OF HER BACK BETWEEN HER SHOULDER BLADES AND IT STARTED 2013 (B)(6). IT WAS INDICATED ONE MONTH PRIOR TO REPORT THE PATIENT HAD SPINAL INJECTIONS FOR SLIPPED DISKS IT WAS STATED THE PATIENT WAS HAVING TROUBLE WITH THEIR IMPLANT, IT WOULDN¿T CHARGE OR CONNECT WITH EITHER THE PROGRAMMER OR RECHARGER. IT WAS STATED THE PATIENT COULDN¿T MOVE HER BACK, TURN OR LOOK DOWN ALONG WITH A SERIOUS MIGRAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362700 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 00037 YR Other