BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1101837 · Received August 7, 2008

    Report

    Report Number
    3004209178-2008-04755
    Event Type
    Injury
    Date Received
    August 7, 2008
    Report Date
    July 9, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEADS, ANCHORS, AND STYLET HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT REPORTED SHE HAD A COUGHING EPISODE AND "IT FELT LIKE MY SPINE WAS RIPPED". AFTER THIS, THE PT COMPLAINED OF DYSESTHESIA IN IPG POCKET, IT WENT UP HER SPINE AND HAD GRABBING PRESSURE IN HER UPPER BACK. DURING SURGERY, THE FIRST LEAD PRODUCED GRABBING IN THE UPPER THORACIC SPINE AREA; THE SECOND LEAD DID NOT PRODUCE EFFECTIVE STIMULATION, SO BOTH LEADS WERE REPLACED. THE HCP ALSO NOTED WHILE ATTEMPTING TO PLACE THE INTRODUCER SHEATH OVER THE STYLET, A BARB ON THE END OF THE STYLET PREVENTED THE SHEATH FROM GOING OVER THE STYLET. THE HCP CHANGED THE STYLET WITH NO FURTHER ISSUES. THE PT RECOVERED WITHOUT SEQUELA. 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 RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention STIM ACCESSORY MODEL STYLET/RESTORE LOT# UNK| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD MODEL 3778 LOT# N0041644| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED:| EXPLANTED:| LEAD MODEL 3778 LOT# N0041646| IMPLANTED:| STIM ACCESSORY MODEL ANCHOR/TLOCK LOT# UNK| IMPLANTED:| STIM ACCESSORY MODEL ANCHOR/TLOCK LOT# UNK| IMPLANTED: