BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3003909 · Received March 14, 2013

    Report

    Report Number
    3004209178-2013-03701
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD COUPLING AND OR COMMUNICATION ISSUES. THE PATIENT HAD GONE WITHOUT CHARGING FOR 1 MO NTH. ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN INDICATED IT WAS UNKNOWN WHAT CAUSED THE ISSUE AND NO INTERVENTION WAS TAKEN. HOSPITALIZATION WAS CHECKED ON THE FORM, BUT WAS IN CONFLICT WITH WHAT WAS REPORTED, AS THERE WAS NO CAUSE AND NO INTERVENTION NOTED. SEVERAL MONTHS LATER, THE PATIENT'S DEVICE WAS SUSPECTED TO BE IN OVERDISCHARGE (OD). THE PATIENT HAD NOT CHARGED IN A "COUPLE" OF MONTHS. ON (B)(6) 2013, THE PATIENT WAS STILL NOTED TO BE IN OD. THE PATIENT MET WITH A COMPANY REPRESENTATIVE AND SOUGHT HELP TO GET THEIR DEVICE OUT OF OD. DURING THIS VISIT, THE RECHARGER SCREEN BECAME UNRESPONSIVE, AND WAS FROZEN ON THE ANTENNA LOCATE SCREEN. THE COMPANY REPRESENTATIVE PLANNED TO RESET THE RECHARGER AND CONTINUE TO TRY ANTENNA LOCATE. ON (B)(6) 2013, IT WAS REPORTED THAT THE DEVICE DID NOT COME OUT OF OD. THE PATIENT PLANNED TO SEE HER PHYSICIAN TO EXPLORE OPTIONS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD THEIR BATTERY REPLACED. THE PATIENT WAS NOTED TO BE DOING GREAT AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107653 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention