BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3935784 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13034
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    June 24, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37092, LOT# 273040001, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT STILL HAD CONCERNS BUT WAS WORKING WITH THEIR PHYSICIAN AND/OR COMPANY REPRESENTATIVE. THE PATIENT HAD APPOINTMENTS ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO RECHARGE THE STIMULATOR. THE REPOSITION ANTENNA SCREEN WAS DISPLAYED. SHE HAD MOVED THE ANTENNA AROUND BUT COULDN¿T GET IT PAST THE REPOSITION ANTENNA SCREEN. THIS STARTED ABOUT A MONTH AGO. THE PATIENT HAD LAST SUCCESSFULLY CHARGED 1-2 MONTHS PRIOR. THE PATIENT LAST FELT STIMULATION 2 MONTHS PRIOR. THE PATIENT WAS ABLE TO COMMUNICATE WITH THE PROGRAMMER BUT DURING THE REPORT, THE PATIENT WAS UNABLE TO DO SO. AN OVERDISCHARGE WAS SUSPECTED. THE PATIENT STATED THAT THIS WAS THE FIRST TIME THIS HAD HAPPENED. IT WAS FURTHER REPORTED THAT A CONFIRMED OVERDISCHARGE HAD OCCURRED. A PHYSICIAN MODE RESET WAS NOT SUCCESSFUL AT RESETTING THE DEVICE. AN EXPLANT WAS PLANNED. IT WAS STATED THAT THE PATIENT HAD GAINED WEIGHT AND THE POCKET WAS DEEPER THAN THE 1 CM RECOMMENDED DEPTH. THE PATIENTS STATUS WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412669 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 00061 YR Required Intervention