BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2854978 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11085
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 6, 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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7435 LOT#, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708340 LOT#, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3487A-33 LOT# N0037378, IMPLANTED: 2004 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED 'EVERYTHING WAS TAKEN OUT; THE AREA WAS INSPECTED THOROUGHLY, AND REPLACED.' THIS OCCURRED ON (B)(6) 2005. IT WAS UNCLEAR IF THE DEVICE WAS EXPLANTED AT THIS POINT, OR IF SOMETHING ELSE WAS MEANT BY REPLACED. NO ISSUES WERE REPORTED. IN (B)(6) 2005, IT WAS NOTED THE SYSTEM WAS REPLACED. IT WAS STATED THE PATIENT OUTCOME 'SEEMED POSITIVE.' NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS ORIGINALLY IMPLANTED IN 2005, IT CAUSED SEVERE PAIN IN THE PATIENT'S STOMACH DUE TO THE LEAD BEING PLACED ON A NERVE. THE LEAD WAS RELOCATED ALONG WITH A PADDLE LEAD PLACED ON (B)(6) 2005. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

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