BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6039875 · Received October 19, 2016

    Report

    Report Number
    3004209178-2016-22025
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    February 9, 2015
    Report Date
    December 6, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE SITE INDICATED THAT ALL IMPEDANCES WERE IN RANGE. IT WAS UNKNOWN IF ANY ACTIONS WERE TAKEN AT THE TIME OF REPORT. RELEVANT MEDICAL HISTORY INCLUDED: SPINAL PAIN, LUMBAR RADICULOPATHY

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE SITE REPORTED A DATA ENTRY ERROR. THE SITE UPDATED THAT ALL IMPEDANCES WERE IN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692273 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97713

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR