BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3970796 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13755
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 9, 2014
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE DEVICE WAS NEVER RECOVERED OUT OF OVERDISCHARGE. THIS WAS STATED TO BE THE REASON FOR REPLACEMENT. THE SYMPTOMS REPORTED WERE LACK OF STIMULATION. NO PRINT-OUTS WERE AVAILABLE. IT WAS THOUGHT THAT THE DEVICE WAS IN CONTINUOUS MODE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AN OVERDISCHARGE (OD) WAS SUSPECTED. THE LAST SUCCESSFUL RECHARGING SESSION WAS 3 WEEKS AGO. THE PATIENTS BACK WAS FEELING BETTER SO HE DECIDED NOT TO CHARGE IT. THE PATIENT NOTED COUPLING/COMMUNICATION ISSUES. THE PATIENT KEPT GETTING THE SCREEN ¿INCORRECT BUTTON HAS BEEN PRESSED.¿ THE PATIENT WAS UNABLE TO GET TO THE REGULAR RECHARGING SCREEN EVEN AFTER ATTEMPTS OF THE ANTENNA LOCATE. IT WAS FURTHER REPORTED THAT THE PATIENTS BATTERY WAS REPLACED, STATED TO BE DUE TO NORMAL BATTERY DEPLETION. THE REASON FOR THE REPLACEMENT WAS UNKNOWN, AS THE BATTERY HAD NOT REACHED THE EXPECTED 9 YEAR MARK. IT WAS UNKNOWN IF THERE WERE OTHER OVERDISCHARGES. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447170 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention