BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3270821 · Received August 8, 2013

    Report

    Report Number
    3004209178-2013-12962
    Event Type
    Injury
    Date Received
    August 8, 2013
    Report Date
    July 16, 2013
    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 377745, LOT# V006729, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 377745, LOT# V011334, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A FRACTURED LEAD ABOUT TWO YEARS PRIOR TO REPORT THAT WAS REVISED. IT WAS STATED THE FRACTURE WAS THOUGHT TO BE DUE TO AN ANCHOR ISSUE. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE WANTED THE DOCTOR TO USE A ¿STRONGER¿ ANCHOR WHEN THE REVISION WAS DONE. REPORTEDLY, THE PATIENT STATED THEY WERE MORE PRONE TO LEAD FRACTURE ISSUES BECAUSE THEY WERE THIN AND THE LEADS STICK OUT OF THEIR SKIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374507 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention