BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3191510 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10945
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    July 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37092, LOT# 240620001, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION. IT WAS NOTED THAT THE PATIENT HAD THE SYSTEM IMPLANTED AND LATER REVISED. IT WAS NOTED THAT THE HEALTHCARE PROFESSIONAL (HCP) SAID THAT THE PATIENT MIGHT HAVE SOME REJECTION FROM THE PADDLE ELECTRODE. IT WAS NOTED THAT THE PATIENT WANTED TO HAVE SPINAL CORD STIMULATION (SCS) SYSTEM IMPLANTED AGAIN. IT WAS NOTED THAT THE PATIENT HAD LOCALIZED PAIN WHERE THE ELECTRODES WERE BUT THERE WAS NO SWELLING AND NO INFECTION. IT WAS FURTHER NOTED THAT AT THE TIME THE SURGEON THOUGHT IT WAS REJECTION AND THEREFORE THE SYSTEM WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS NOTED AS THE LEAD. POSSIBLE REJECTION WAS NOTED. SIGNS AND SYMPTOMS INVOLVED BACK PAIN WHERE THE PADDLE LEADS IMPLANTED. HOSPITALIZATION WAS NOT REQUIRED. PADDLE LEADS EXTRACTED WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290077 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 00043 YR Required Intervention