BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2792360 · Received October 16, 2012

    Report

    Report Number
    3004209178-2012-09213
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT BURNING AT POCKET SITE EVEN WHEN STIM WAS OFF. THE DOCTOR EXPLANTED THE DEVICE ON (B)(6) 2012. THE PATIENT STATUS AT TIME OF THIS REPORT WAS ALIVE - NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention