BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2831576 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10240
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, *UNKN-LD LOT# SERIAL# (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS EXPLANTED. IT WAS UNCLEAR WHAT WAS EXACTLY EXPLANTED. IT WAS INDICATED THAT THE MANUFACTURER REPRESENTATIVE WAS GOING TO MEET WITH THE PATIENT AT THE DOCTOR'S OFFICE ON (B)(6). THIS APPOINTMENT WAS TO ADJUST COVERAGE IN THE PATIENT'S LEFT LEG. IT WAS STATED THAT THE PATIENT WAS RECEIVING "GREAT COVERAGE EVERYWHERE ELSE." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REQUEST. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGICAL REVISION WAS PERFORMED. NO OTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL IN FORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    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