BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2870643 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11759
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 20, 2012
    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, 8591-38 LOT# D26866, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3776-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3776-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3550-39 LOT# N294753, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-14 LOT# N318812, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-14 LOT# N303331, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GOING TO TRY NEW PROGRAMMING. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PAINFUL STIMULATION AND TREMORS. IT WAS STATED THAT THE STIMULATION OCCURS IN THE DESIRED AREAS, BUT WAS IRRITATING THE PATIENT. THE PATIENT WAS EXPERIENCING TREMORS WHICH BEGAN AFTER BEING IMPLANTED WITH THE DEVICE. IT WAS REPORTED THAT THE STIMULATION DID NOT HELP PAIN. IT WAS NOTED THAT THE PATIENT WAS LEFT FEELING "VERY UNCOMFORTABLE" AS A RESULT OF STIMULATION WHEN THE DEVICE WAS TURNED OFF. X-RAYS OF THE LEADS SHOW THAT THEY WERE STAGGERED BY APPROXIMATELY 0.5 -1 VERTEBRAL BODY. IT WAS UNKNOWN IF THERE WAS A LEAD MIGRATION OR IF THIS WAS PLACEMENT AT THE TIME OF SURGERY. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. IT WAS STATED THAT THE PATIENT WAS REPROGRAMMED. THE PATIENT WAS REPORTED TO ALIVE WITH NO INJURY OR ADVERSE EFFECT. FURTHER INFORMATION HAS BEEN REQUESTED BUT WAS UNAVAILABLE 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 MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1