BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1823467 · Received August 25, 2010

    Report

    Report Number
    3004209178-2010-06415
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 27, 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, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS IN THE WRONG LOCATION. IT WAS STATED STIMULATION WAS FELT UNDER LEFT BREAST BY PATIENT'S RIBS AND NO STIMULATION IN HER LOW BACK WHICH WAS THE TARGETED AREA. IT WAS REVIEWED THAT POSSIBLE SWELLING MAY HAVE AFFECTED WHERE STIMULATION WAS FELT. PATIENT HAD SURGERY ON (B)(6) 2010 TO RE-POSITION THE PADDLE. IT WAS TO BE DETERMINED IF PATIENT WAS STILL HAVING PROBLEMS WITH HER DEVICE SYSTEM. ADDITIONAL INFORMATION WILL BE PROVIDED WHEN AVAILABLE.

    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 55 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V407910022| PROGRAMMER: MODEL 37743, LOT# NKE145916N| EXPLANTED:| IMPLANTED: