BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3000518 · Received March 12, 2013

    Report

    Report Number
    3004209178-2013-03619
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    February 20, 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

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS NON-MALIGNANT PAIN/OCCIPITAL NEURALGIA. PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS "HURTING SO MUCH" THEY WERE TAKEN TO THE EMERGENCY ROOM TWO NIGHTS PRIOR TO REPORT AND THE NIGHT OF THE REPORT. IT WAS ALSO REPORTED THE PATIENT WAS EXPERIENCING PAIN FROM THE WIRE AND BY THE NERVE. IT WAS REPORTED THE PATIENT HAD A BUILD-UP OF SCAR TISSUE AND HAD THE PAIN SINCE THE DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTEDLY PRESCRIBED STEROIDS TO REDUCE THE PAIN, THEN TAKEN OFF STEROIDS AND PRESCRIBED PAIN RELIEVERS, THEN TAKEN OFF THE PAIN RELIEVERS A FEW DAYS PRIOR TO REPORT. IT WAS REPORTED THE PATIENT HAD BEEN IN "EXTREME PAIN" AFTER BEING TAKEN OFF PAIN RELIEVERS AND IT WAS REPORTED THE STIMULATION HAD BEEN TURNED OFF. IT WAS ALSO REPORTED THE PATIENT HAD BEEN HAVING CHRONIC MIGRAINES FOR THE PAST EIGHT YEARS AND THE DEVICE DID NOT PROVIDE RELIEF AND CAUSED HER TO THROW UP. THE PATIENT HAD AN X-RAY DONE AND IT WAS REPORTED THE HEALTHCARE PROVIDER WANTED TO REMOVE THE DEVICE AND THE PATIENT WAS SCHEDULED TO HAVE IT EXPLANTED (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103335 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention