BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1201513 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06674
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STIMULATOR WAS RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE STIMULATOR REACHED END OF SERVICE (EOS) AFTER FOUR MONTHS. THE STIMULATOR WAS USED 24 HOURS. THE BATTERY LONGEVITY CALCULATION ESTIMATE (AT THE PROGRAMMED SETTINGS) WAS TWO MONTHS. THE PATIENT EXPERIENCED PAIN AT THE STIMULATOR POCKET SITE. THE STIMULATOR WAS PROGRAMMED AT: ELECTRODE A1: PULSE WIDTH 450 USEC; RATE: 120HZ; AMPLITUDE 6.8 VOLTS, GROUP IMPEDANCE 879 OHMS, 7,705 MA. ELECTRODE A2: PULSE WIDTH 450 USEC; RATE 120 HZ; AMPLITUDE 7.6 VOLTS; GROUP IMPEDANCE 278 OHMS, 24,891 MA. THE STIMULATOR WAS EXPLANTED BUT NOT REPLACED. THERE WERE SIGNIFICANT SIGNS OF GRANULATED AND INFLAMMATORY TISSUE. WHITE COLORED TISSUE WAS FOUND INSIDE THE POCKET. THE PATIENT WAS FINE AFTER EXPLANT SURGERY. THE PATIENT WILL UNDERGO HIP SURGERY IF THE PAIN PERSISTS. THE PATIENT WILL RECEIVE A NEW SPINAL CORD STIMULATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention