BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3050301 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05857
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 28, 2021
    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
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3587A, LOT# LB9525, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS FOR THE LEAD LB9525 REVEALED THE PROXIMAL END OF THE OUTER INSULATION IN THE CONNECTOR AREA HAD METAL INDUCED OXIDE. FINAL DEVICE ANALYSIS FOR THE EXTENSION NKC005807N REVEALED THE OUTER INSULATION WAS CUT.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    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'S LEAD AND EXTENSION WERE REMOVED SEVERAL MONTHS AGO AND WERE BEING RETURNED TO THE MANUFACTURER FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148503 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention