BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2971804 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02935
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    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 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37754, LOT# SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3550-39, LOT# N314552, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING "SEVERE POST-OPERATIVE PAIN" WHILE IN THE POST-ANESTHESIA CARE UNIT (PACU). IT WAS NOTED THAT THE PATIENT WAS BEING ADMITTED TO THE HOSPITAL. IT WAS FURTHER NOTED THAT THE PATIENT'S DEVICE WOULD BE PROGRAMMED "AS SOON AS SHE WAS ABLE". IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REFER TO MANUFACTURING REPORT # 3004209178-2013-02778.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76649 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 Hospitalization