BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 8670254 · Received June 5, 2019

    Report

    Report Number
    3004209178-2019-10916
    Event Type
    Injury
    Date Received
    June 5, 2019
    Report Date
    June 5, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW, EXPLANT OF THIS INS WAS ALREADY REPORTED IN A PRIOR REGULATORY REPORT. PLEASE SEE REG REPORT #: 3004209178-2017-18289. A SUPPLEMENTAL REPORT WILL BE SENT IN THAT REG REPORT AND ALL FUTURE UPDATES RELATED TO THIS FILE WILL BE SUBMITTED IN THAT REG REPORT. 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 REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR RADICULAR PAIN SYNDROME (RADICULOPATHIES) AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS THINKING THEIR DEVICE WAS EXPLANTED AND THE POCKET REVISED BECAUSE THEIR BODY HAD REJECTED THE DEVICE. NO DEVICE ISSUES WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465491 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention