BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4266112 · Received November 20, 2014

    Report

    Report Number
    3004209178-2014-21962
    Event Type
    Injury
    Date Received
    November 20, 2014
    Report Date
    October 27, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE/THERAPY WAS USED FOR AN OFF-LABEL INDICATION: OCCIPITAL MIGRAINES. CONCOMITANT PRODUCTS: PRODUCT ID 3550-29, LOT# N310192, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 3708140, SERIAL # (B)(4)IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3986A60, LOT # N280989, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3986A60, LOT # N280985, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S THERAPY WAS FOR OCCIPITAL MIGRAINES. THE GENERATOR WAS IN THE PATIENT¿S BACK. THE ¿ONE FROM 2012¿ WAS TAKEN OUT BECAUSE THE PATIENT HAD PAIN IN HER RIBCAGE FOR 10 MONTHS. IT WAS MOVED TO HER ABDOMEN IN 2012. THE PATIENT HAD APPROVED THE PLACEMENT PRIOR TO THE PROCEDURE. IT KEPT GETTING ¿HOOKED¿ ON HER RIBCAGE. IT HURT SO BAD IT FELT LIKE A HEART ATTACK. IT WAS NOT CONSTANT; THE PATIENT THOUGHT IT WAS POSITIONAL. THEY TRIED A BRACE BUT THE PAIN GOT WORSE AND WORSE. THE PATIENT HAD TO WRAP HER WHOLE BODY IN AN ACE WRAP TO BE COMFORTABLE DURING THE 10 MONTHS. THE PATIENT HAD LOST WEIGHT AND THAT MAY HAVE AFFECTED THE GENERATOR IN HER ABDOMEN. THE IMPLANT WAS REPLACED IN 2014. THE LEADS WERE NOT REPLACED. THE PATIENT¿S OUTCOME COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. IF ADDITIONAL FOLLOW-UP IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755023 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