BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2760742 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08542
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 13, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-75 SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2012-08-29 PRODUCT TYPE LEAD PRODUCT ID, 3778-75 SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37742 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE ENTIRE IMPLANTABLE NEUROSTIMULATOR SYSTEM EXPLANTED DUE TO MIGRATED LEADS AND AN OVER-DISCHARGED BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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