BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2931036 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01023
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 8, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CEREBROSPINAL FLUID (CSF) LEAK POST-PROCEDURE. THERE WAS NO PATIENT INJURY BUT SURGICAL INTERVENTION WAS REQUIRED TO REPAIR DURA WITH A BLOOD PATCH. SURGERY WAS SCHEDULED FOR THE FOLLOWING DAY. PATIENT SYMPTOM OF HEADACHE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37449 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 Required Intervention