BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3191209 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10924
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    October 2, 2018
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-33, LOT# V360222, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3888-33, LOT# V360222, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 3888-33, LOT# V360222, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3888-33, LOT# V360222, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE LEADS REMOVED AND THE HCP (HEALTHCARE PROFESSIONAL) WAS ADVISED TO LEAVE IN THE INS (IMPLANTABLE NEUROSTIMULATOR) SINCE THE PATIENT WOULD STILL BE ABLE TO DO FULL BODY MRI. IT WAS STATED THAT THE PATIENT WAS EXPECTING TO GET THE INS AND LEADS REMOVED. MORE THAN ONE WEEK LATER IT WAS REPORTED THAT THE PATIENT WAS RECEIVING AN MRI IN TWO DAYS. THREE DAYS LATER IT WAS REPORTED THAT THE MRI HAD BEEN PERFORMED AND NOTHING WAS HEARD REGARDING ANY ISSUES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL (HCP). IT WAS REPORTED THAT LEADS AND EXTENSIONS WERE REMOVED IN 2013. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289771 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