BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3852167 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10222
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# V342014, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 74002, LOT# N267640, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS HAD TROUBLE TURNING THEIR IMPLANT ON THE LAST COUPLE OF DAYS PRIOR TO THE DATE OF THE REPORT. IT WAS FURTHER REPORTED THAT ON THE MORNING OF THE DATE OF THE REPORT THE PATIENT GOT THE DOCTORS FACE WITH 006 ERROR CODE. IT WAS NOTED THAT THE PATIENT HAD NOT SPILLED ANYTHING STICKY ON IT. THE PATIENT THEN TRIED TO USE THEIR PATIENT PROGRAMMER AND IT WORKED FINE. THE PATIENT WAS INFORMED THAT IF A BUTTON IS PUSHED TOO LONG IT CAN GIVE THE 006 ERROR CODE. THE PATIENT¿S SETTINGS ALSO REPORTEDLY HAD CHANGED FROM 6.2 WHERE THEY HAD IT. THE PATIENT WAS INFORMED THAT THE IMPLANT WILL BRING UP THE LAST SETTINGS THAT IT MEMORIZED. THE PATIENT PROGRAMMER WAS REPORTEDLY WORKING AT THE TIME OF THE REPORT AND THE ACTIONS RESOLVED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329511 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 00057 YR