BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6673638 · Received June 28, 2017

    Report

    Report Number
    3004209178-2017-13899
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    May 5, 2017
    Report Date
    June 28, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109513
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977C265, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. INFORMATION WAS PREVIOUSLY REPORTED UNDER MANUFACTURER¿S REPORT 2649622-2017-07568 AND WAS DETERMINED AFTER FURTHER REVIEW TO BE THE INCORRECT DEVICE. ALL CURRENT AND FUTURE INFORMATION WILL NOW BE REPORTED UNDER THE CURRENT MANUFACTURER¿S REPORT. ALL PREVIOUS EVALUATION CODES NO LONGER APPLY AND THE CURRENT CODES ARE TO BE USED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A NEW TYPE OF PAIN AND SPASMING AT THE TIME THEY ADJUSTED STIMULATION AFTER THEY WERE IMPLANTED AND THE DEVICE WAS TURNED OFF. THE PATIENT HAD A LEAD REVISION IN WHICH THE PADDLE WAS REMOVED AND REPLACED BY PERCUTANEOUS LEADS. AT THE TIME OF THE REVISION THE PHYSICIAN NOTED A FLUID BUILD-UP AROUND THE PADDLE AND INDICATED THAT THIS MAY BE THE REASON FOR THE PAIN AND SPASMING THE PATIENT WAS EXPERIENCING. AT THE TIME OF THE REVISION THE PATIENT WAS PROGRAMMED AND THE DEVICE WAS TURNED ON TO A LOW LEVEL. THREE TO FOUR DAYS LATER THE PATIENT FELT PAIN AND SPASMING AGAIN. DURING PROGRAMMING WITH THE LEADS THE PATIENT FELT A GRABBING SENSATION AND THE LEFT LEAD CAUSED DISCOMFORT. IMPEDANCES WERE TESTED AND WERE WITHIN 922-1100 OHMS. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAD HIS FULL SYSTEM REMOVED AND IT WAS NOTED THAT A REPRESENTATIVE WAS NOT PRESENT. THE CONSUMER REPORTED THAT HE WAS DOING GOOD. NO FURTHER COMPLICATIONS WERE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453167 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702 00643169109513

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention