BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2966327 · Received February 18, 2013

    Report

    Report Number
    3004209178-2013-02767
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Report Date
    May 4, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3776-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37092, LOT # 271470001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 37082-20, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-45, LOT # V185448, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # V130379, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE FOLLOW-UP 2 INSTANCES OF OVERDISCHARGE WERE CONFIRMED. PATIENT NON-COMPLIANCE WAS STATED AS THE REASON FOR THE OVERDISCHARGE. POWER ON RESET (POR) OCCURRED AND WAS NOT CLEARED SUCCESSFULLY. PATIENT STATUS AT TIME OF THIS REPORT WAS STATED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT. IT WAS UNKNOWN WHAT ACTIONS WERE REQUIRED AS A RESULT OF THE EVENT. THE STATUS OF THE DEVICE WAS NOTED AS IMPLANTED - OUT OF SERVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70389 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1