BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5646975 · Received May 11, 2016

    Report

    Report Number
    3004209178-2016-09276
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    November 1, 2015
    Report Date
    June 6, 2016
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3888-45, LOT# V184882 , IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-45, LOT# V191582, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, LOT# V177008005, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL (HCP) REPORTED SEEING A PATIENT WHO HAD A SPINAL CORD STIMULATOR PLACED AT ANOTHER PRACTICE FOR FAILED BACK SYNDROME (5 YEARS AGO). ABOUT 6 MONTHS AGO, HE BEGAN EXPERIENCING RECURRENT PAIN AND PARESTHESIA THOUGH NEUROLOGICALLY INTACT. A CT SCAN WAS DONE AND IT APPEARED THAT THE EPIDURAL LEADS HAVE A SUBDURAL/INTRATHECAL LOCATION. THE HCP WAS TRYING TO DETERMINE THE BEST COURSE OF ACTION TO REMOVE THE SYSTEM, AS THAT CARRIES SIGNIFICANT RISKS, OR THE LAMINOTOMY PLACEMENT OF A PADDLE LEAD LEAVING THE INTRATHECAL LEAD IN PLACE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED A CT SCAN DEMONSTRATED LEAD MIGRATION, NO PRODUCT ISSUES WERE NOTED, AND THE C ONSUMER WAS TO BE REFERRED TO ANOTHER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303097 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