BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3012812 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03966
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 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

    PRODUCT ID 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ON 2013 (B)(6). SINCE THE FALL, THE PATIENT HAS HAD INTERMITTENT STIMULATION AND A SHOCKING OR JOLTING SENSATION WITHOUT BODY MOTION. IT WAS ALSO REPORTED, THE PATIENT EXPERIENCED PARESTHESIA HIGHER ON HER BODY THAN BEFORE THE FALL ALONG WITH STIMULATION IN THE BELLY. IMPEDANCE VALUES WERE CHECKED AND WERE WITHIN THE NORMAL RANGER. REPROGRAMMING WAS PERFORMED BUT DID NOT RESOLVE THE ISSUES. A THORACOLUMBAR X-RAY WAS PERFORMED TO CHECK LEAD PLACEMENT. THE PATIENT ALSO REPORTED INADEQUATE PAIN RELIEF ON BOTH HER RIGHT AND LEFT SIDE. IT WAS LATER REPORTED THAT THE X-RAYS SHOWED NO LEAD MIGRATION. THE PATIENT WAS SCHEDULED TO RETURN TO THE PHYSICIAN'S OFFICE ON 2013 (B)(6). THE PATIENT WAS STILL EXPERIENCING INTERMITTENT STIMULATION WITH SHOCKING OR JOLTING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMED THE DEVICE. IT WAS STATED THAT THE PATIENT WAS "DOING OK" WHEN SHE LEFTAND THAT THE STIMULATION "WAS OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115976 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 00066 YR