BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3113770 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07704
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS STATED THAT IT WAS UNKNOWN IF THE EVENT WAS DUE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) OR THE LEAD/EXTENSION. IT WAS NOTED THAT IT WAS UNKNOWN IF THE EVENT WAS DUE TO THE PROGRAMMING OR PROGRAMMER. IT WAS REPORTED THAT THERE WAS EXPLORATORY SURGERY OF THE SURGICAL SITE THE SAME DAY AS THE PADDLE LEAD IMPLANT BUT NO ABNORMALITIES WERE FOUND. IT WAS NOTED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT, AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INITIALLY AFTER A NORMAL PADDLE LEAD IMPLANT, PLACED AT THE NINTH THORACIC VERTEBRAE, THE PATIENT FELT FINE WITH GREAT STIMULATION COVERAGE; HOWEVER, 1.5 TO 2 HOURS LATER, THE PATIENT WAS NOT "FEELING" HER LEGS. IT WAS NOTED THAT THE STIMULATION WAS OFF AT THAT TIME. IT WAS FURTHER NOTED THAT LATER THE SAME DAY, THE PATIENT WAS ABLE TO FEEL SOME SENSATION TO HER LEGS. IT WAS NOTED THAT A SECOND SURGERY WAS PERFORMED AND THE PHYSICIAN "OPENED POCKET TO LAMINOTECTOMY." IT WAS UNCLEAR IF ANYTHING WAS REMOVED DURING THE SECOND SURGERY. IT WAS FURTHER NOTED THAT AFTER THE SECOND SURGERY, THE PATIENT HAD A RETURN OF SENSATION OF BOTH LEGS. IT WAS NOTED AN EMG WAS PERFORMED AND THE READINGS WERE THE SAME AS "PREVIOUS INITIAL SURGERY." IT WAS NOTED THAT THE PATIENT FELT GREAT SIMULATION AND HAD AS GREAT OF COVERAGE AS THE TRIAL. IT WAS FURTHER NOTED THAT THE PATIENT OUTCOME WAS REPORTED AS FINE WITH NO INJURY AND THE PATIENT RETURNED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214966 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