BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2960928 · Received February 14, 2013

    Report

    Report Number
    3007566237-2013-00449
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TELEMETRY AND INTERROGATION ISSUES, AND TELEMETRY WAS NOT POSSIBLE ANYMORE. THE REPORTER STATED THAT THEY WANTED TO OPEN THE DEVICE POCKET. IT WAS UNCLEAR WHAT THEY WANTED TO DO AFTER THE POCKET HAD BEEN OPENED OR IF THEY WANTED TO MOVE OR REPLACE THE DEVICE. THERE WERE NO PATIENT SYMPTOMS AND THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROCEDURE DID NOT TAKE PLACE AND NO X-RAY HAD BEEN PERFORMED. IT WAS NOTED THAT HE STIMULATOR WAS STILL NOT RESPONDING AND COULD NOT BE RECHARGED. IT WAS FURTHER REPORTED THAT NO OTHER INFORMATION WAS AVAILABLE. IF MORE INFORMATION IS RECEIVED IT WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66109 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention