BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2990092 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03326
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 18, 2013
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3776-45 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3776-45 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3550-39 LOT# N337015, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. IT WAS NOTED THAT THE PATIENT'S DEVICE WAS REPROGRAMMED ONCE, BUT THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A POCKET REVISION ON (B)(6) 2013. THE REASON FOR THE REVISION WAS THAT THE DEVICE WAS NOT "DEEP ENOUGH." NOTHING WITHIN THE SYSTEM CHANGED DURING THE REVISION. PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93235 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention