BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2854747 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11075
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 5, 2012
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-45, LOT# V433248, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V205388, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-39, LOT# N243274, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT THREE MONTHS POST IMPLANT, THE THERAPY STOPPED HELPING A PATIENT AND HE ENDED UP HAVING THE IMPLANTABLE N NEUROSTIMULATOR REMOVED. THE REPORTER STATED THAT THE DEVICE WAS SUPPOSED TO HELP WITH NECK AND BACK PAIN SO THAT HE COULD LOWER OR DISCONTINUE THE USE OF ORAL MEDICATION, BUT IT DIDN'T HELP AND THE PATIENT USED MORE MEDICATION. IT WAS REPORTED THAT THE LEADS BUNCHED UP IN THE PATIENT'S NECK AND CAUSED HIM PAIN. IT WAS REPORTED THAT THE PATIENT'S HEALTH CARE PROVIDER (HCP) WOULD NOT AGREE TO REMOVE THE LEADS BECAUSE HE DIDN'T PERFORM THE IMPLANT, IT WAS "TOO RISKY," AND THE HCP DIDN'T WANT TO BE LIABLE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED TO SEE THIS HCP ON (B)(6) 2012. THE REPORTER STATED THAT THE IMPLANTING PHYSICIAN WOULD NOT RETURN THE PATIENT'S PHONE CALLS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. IT WAS ALSO NOTED THE PATIENT'S ORIGINAL DOCTOR WAS NO LONGER THEIR DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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