BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2927379 · Received January 23, 2013

    Report

    Report Number
    3004209178-2013-00901
    Event Type
    Injury
    Date Received
    January 23, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3986A LOT# N140021, PRODUCT TYPE LEAD PRODUCT ID, 3986A LOT# N125489, PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37083-40 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID, 37083-40 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT MOTOR CORTEX GENERATOR IMPLANTATION OF HER RIGHT HAND ON (B)(6) 2008. IT WAS STATED THAT THIS WAS THE PATIENT'S "WORST COMPLAINT". AT THE TIME THE PATIENT HAD "GOOD" CONTROL OF HER RIGHT HAND PAIN WHICH HAD PREVIOUSLY BEEN AT 10/10 PAIN AND WAS CONTROLLED TO ABOUT A 6/10. HOWEVER, FOLLOWING SURGERY THE PATIENT'S LEFT ARM AND LEG PAIN INCREASED. IT WAS STATED THAT THE PATIENT RECEIVED AN IMPLANT FOR THIS PAIN A YEAR LATER. NO FURTHER INFORMATION ON THIS EVENT WAS PROVIDED. FOR MORE INFORMATION ON THIS DEVICE PLEASE REFER TO MANUFACTURER NUMBER 3004209178-2012-09645.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33131 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 Required Intervention