BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1750103 · Received July 7, 2010

    Report

    Report Number
    3004209178-2010-05289
    Event Type
    Injury
    Date Received
    July 7, 2010
    Report Date
    June 9, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED DUE TO BATTERY DEPLETION. THE NURSE REPORTED THAT IT WAS NOT CLEAR THAT IT WAS THE NORMAL TIME FRAME AS IT SEEMED TO BE FAST. THE SETTING OF THE DEVICE, AS REPORTED BY THE NURSE WERE GROUP A: RATE 40-65-65, PROGRAM 1 1+2-3+ PW 200 (RANGE 150-210), PROGRAM 2 11+12-13+ PW 190 (RANGE 150-210), PROGRAM 3 1+2+6+7- 8+12+13+ PW 200 (RANGE 150-210), AND PROGRAM 4 0+1+5+6-7+11+12+ PW 200 (RANGE 150-210); GROUP B: RATE 40-75-85, PROGRAM 1 0+1-2+ PW 210 (RANGE 150-210) AND PROGRAM 2 11+12-13+ PW 210 (RANGE 150-210); AND GROUP C: PROGRAM 1 1+2-3+ PW 210 (RANGE 150-210) AND PROGRAM 2 11+12-13+ PW 210 (RANGE 150-210). THE USAGE FOR EACH GROUP AND PROGRAM WERE NOT PROVIDED. NO PATIENT SYMPTOMS OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention