BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1842010 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-07130
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    June 14, 2010
    Report Date
    August 26, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED A CHANGE IN SENSATION OF STIMULATION. X-RAY RESULTS SHOWED THE EPIDURAL CATHETER IN PLACE ON (B)(6)2010. PATIENT EXPERIENCED A LOSS OF LOW BACK STIMULATION AND WAS REPROGRAMMED. IT WAS SUBSEQUENTLY REPORTED THAT THE LEAD MIGRATED. THE SURGEON IMPLANTED 4 QUADS - 3 ANTEGRADE AND 1 RETRO. THE SURGEON USED TITAN ANCHORS ON THE ANTEGRADE LEADS, WHICH MIGRATED CEPHALAD. THE LEFT MOVED WAY UP INTO T3-4 AND THE MIDDLE AND RIGHT LEADS MOVED UP INTO T6-7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention ACCESSORY: MODEL 37752, LOT# NKA139054N| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED: | EXTENSION: MODEL 37082, LOT# NKB004001V| EXTENSION: MODEL 37082, LOT# NKB004983V| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V391333| LEAD: MODEL 3487A, LOT# V400923| LEAD: MODEL 3487A, LOT# V409879| LEAD: MODEL 3487A, LOT#V400923| PROGRAMMER: MODEL 37743, LOT# NKE144297N| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE144297N| LEAD: MODEL 3487A, LOT# V409879| LEAD: MODEL 3487A, LOT# V391333| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT#V400923| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V400923| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA139054N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB004001V| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB004983V| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: