BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1120767 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-05011
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    June 25, 2007
    Report Date
    July 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS SUBMITTED LATE BY THE MANUFACTURER'S REPRESENTATIVE, RETRAINING HAS BEEN CONDUCTED. IT IS UNCLEAR WHAT IS MEANT BY THE 'STRAW'.

    Description of Event or Problem · 1

    DURING PLACEMENT OF A SPINAL CORD STIMULATOR THE 'STRAW' WAS LEFT IN THE PT. THE SURGEON REMOVED THE STRAW FROM THE EXTENSION KIT. THE SURGEON SCREWED THE OBTURATOR TIP ONTO THE TUNNELING TOOL, TUNNELED SUBCUTANEOUSLY TO CREATE A PATH FOR THE EXTENSION, AND UNSCREWED THE OBTURATOR TIP FROM THE TUNNELING TOOL. THE SURGEON INSERTED THE STRAW INTO THE TOOL, REMOVED THE TUNNELING TOOL, AND PASSED THE EXTENSION THROUGH THE STRAW. THE STRAW WAS LOST AT THIS TIME. THE SURGEON WAS UNABLE TO LOCATE IT AND WAS THEREFORE UNABLE TO REMOVE IT. THE SURGEON MAY HAVE MADE AN INCISION BETWEEN THE TUNNELING ENTRY AND EXIT POINTS IN AN ATTEMPT TO FIND THE STRAW. THE STRAW IS NOT RADIOLUCENT. NO PT SYMPTOMS WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention EXPLANTED:| EXTENSION MODEL 37082 LOT# NKB002627N| LEAD MODEL 3987A LOT# N106122| EXPLANTED:| IMPLANTED:| LEAD MODEL 3987A LOT# N110982| IMPLANTED:| EXPLANTED:| IMPLANTED: