BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2918777 · Received January 16, 2013

    Report

    Report Number
    3004209178-2013-00669
    Event Type
    Injury
    Date Received
    January 16, 2013
    Report Date
    December 26, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377775, LOT # V008543, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377760, LOT # V012045, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT # V010660, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT # V010634, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICES WERE "NOT WORKING WELL AT ALL." IT WAS STATED THE PATIENT HAD BEEN IN "CRISIS MODE FOR THE PAST 3 MONTHS. THE PATIENT HAD BEEN IN THE HOSPITAL FROM (B)(6) 2012. IT WAS FURTHER STATED THE CAUSE FOR THE PATIENT'S ISSUES WAS DUE TO THE "DEVICES NOT OPERATING PROPERLY." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED. REFER TO THE MANUFACTURER REPORT #3004209178-2013-00668. THE PATIENT HAS TWO SYSTEMS IMPLANTED AND BOTH ARE MENTIONED AS CAUSES OF THE PATIENT'S ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24400 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 Hospitalization