BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4285144 · Received November 29, 2014

    Report

    Report Number
    3004209178-2014-22295
    Event Type
    Injury
    Date Received
    November 29, 2014
    Report Date
    November 7, 2014
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 389056, LOT# V042809, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 389056, LOT# V042809, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 389056, LOT# V033964, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 389056, LOT# V042809, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A FULL SYSTEM REPLACEMENT OF LEADS AND EXTENSIONS DUE TO HIGH IMPEDANCES ON MULTIPLE LEADS. THE PATIENT WAS DOING WELL NOW WITH EFFECTIVE THERAPY. IT WAS NOTED THAT THE PRODUCT WAS GOING TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773113 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention