BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4248212 · Received November 13, 2014

    Report

    Report Number
    3004209178-2014-21492
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    July 16, 2007
    Report Date
    November 11, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3998, LOT# V022880, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3998, LOT# V022880, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE HELPED THEM FOR TWO MONTHS. DURING THOSE TWO MONTHS THE PATIENT ¿FELT SOMETHING PULLING IN THERE¿ AND THEN IT QUIT WORKING. THE PATIENT MET WITH THEIR MANUFACTURER REPRESENTATIVE WHO CHECKED THE DEVICE AND IT WAS DETERMINED THE LEAD HAD BROKEN OR SHORTED OUT AND NEED TO BE REPLACED. THE PATIENT STATED THE WHEN THEY WERE ORIGINALLY IMPLANTED THE MANUFACTURER REPRESENTATIVE GAVE THE HEALTH CARE PROVIDER (HCP) WIRES THAT WERE NOT LONG ENOUGH WHICH HAD CAUSED THEM TO PULL LOOSE AND BREAK. THE PATIENT HAD A REVISION ON 2008-(B)(6) WHERE THEY DISCOVERED THE LEADS HAD ¿PULLED CLOSER TO THE SPINE¿ CAUSING THE DEVICE TO ONLY WORK ON ONE SIDE IN A LIMITED REGION. AS A RESULT THE STIMULATION WAS NOT WHERE THE PATIENT NEEDED IT AND THEY HAD A LOSS OF THERAPEUTIC EFFECT ON ONE SIDE. AFTER THE REVISION THE PATIENT WENT TO THEIR HEALTH CARE PROVIDER (HCP) TO HAVE IT ADJUSTED TWICE AND FOUND THAT ¿IT DOES NOT WORK IN THE WAY IT SHOULD¿ SO THEIR DEVICE WAS USELESS AND THEY WANTED IT EXPLANTED. AFTER THE REVISION THE PATIENT STILL DID NOT HAVE GOOD STIMULATION ON THE LEFT SIDE. THE PATIENT HAS SINCE STOPPED CHARGING THE DEVICE BECAUSE THE HCP STATED ¿IT COULD NOT BE MOVED BACK IN PLACE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731844 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention