BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2820949 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09949
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 355531, LOT# N333672, IMPLANTED: (B)(6) 2012, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 3550-14, LOT# N333405, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3550-14, LOT# N333405, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. IT WAS REPORTED THAT THE PATIENT GOT A 'CALL YOUR DOCTOR' ICON AND THAT THERE WAS AN OUT OF REGULATION (OOR) CONDITION. THE PATIENT TRIED TO TURN OFF HER STIMULATION, BUT WHEN SHE PRESSED THE 'SYNC' KEY SHE RECEIVED THE OOR MESSAGE AND THE DEVICE 'SHUT ITSELF OFF.' WHEN THE PATIENT TRIED TO TURN THE STIMULATION BACK ON SHE AGAIN SAW THE OOR. THE PATIENT HAD WANTED THE STIMULATION OFF BECAUSE HER STOMACH WAS BOTHERING HER AND THE STIMULATION 'SOMETIME MAKES IT WORSE.' IT WAS FURTHER REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS REPORTED THAT THE STIMULATION ON THE PATIENT'S LEFT SIDE IS 'SKITTISH' AND SHE CANNOT FEEL IT ON HER LEFT SIDE 'ALL THE TIME.' IN ORDER TO FEEL STIMULATION ON THE LEFT SIDE THE PATIENT HAD TO REPOSITION/TWIST OR PUT PRESSURE ON THE DEVICE. WHILE MAKING THE REPORT THE PATIENT WAS SITTING UPRIGHT AND COULD NOT FEEL STIMULATION ON HER LEFT SIDE BUT WHEN SHE APPLIED PRESSURE TO THE DEVICE SHE COULD FEEL IT ON BOTH SIDES. IT WAS NOTED THAT THE RIGHT SIDE 'WORKS GOOD.' IT WAS ALSO REPORTED THAT THE PATIENT WAS IN THE HOSPITAL (B)(6). THE PATIENT WAS 'VIOLENTLY VOMITING' DURING BOTH HOSPITAL STAYS. IT WAS AFTER THE FIRST HOSPITAL STAY IN AUGUST THAT SHE STARTED HAVING ISSUES WITH THE LEFT SIDE. ADDITIONAL INFORMATION HAD BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1