BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1833175 · Received September 9, 2010

    Report

    Report Number
    3004209178-2010-06897
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 17, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICES HAVE BEEN RETURNED TO THE MFR 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

    IT WAS REPORTED THAT THE PT REQUESTED TO HAVE THE SPINAL CORD STIMULATOR (SCS) SYSTEM REMOVED BECAUSE, THE PT WAS DISSATISFIED WITH THE STIMULATION COVERAGE (OF PAIN). DESPITE MULTIPLE REPROGRAMMING ATTEMPTS, THE PT REPORTED INTERMITTENT STIMULATION. NO OBVIOUS MALFUNCTIONS OR ABNORMALITIES OF THE SCS EQUIPMENT WERE DISCOVERED OR OBSERVED. IT WAS NOTED THAT THE LEAD WAS CUT DURING THE EXPLANT PROCEDURE. NO FURTHER DETAILS OR PT SYMPTOMS WERE PROVIDED AT THE TIME OF THIS REPORT. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE149631N| EXPLANTED:| LEAD: MODEL 39286-65, LOT # V416017003| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA141491N| IMPLANTED:| EXPLANTED: