BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 8621325 · Received May 17, 2019

    Report

    Report Number
    3004209178-2019-09846
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 10, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP) INDICATED THAT THERE WAS NOTHING SPECIFIC AS TO WHY THE PATIENT WAS NO LONGER GETTING PAIN RELIEF. THE PATIENT INDICATED THAT THEIR DEVICE WAS WORKING FINE, THEY WERE JUST NOT HAPPY WITH THE LEVEL OF PAIN RELIEF THEY WERE RECEIVING. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) AND MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). INFORMATION WAS REPORTED THAT THE PATIENT DIDN'T HAVE AN ISSUE WITH THE DEVICE, BUT STATED THE INS WAS NOT PROVIDING ENOUGH PAIN RELIEF. THE PATIENT DECIDED TO HAVE THEIR INS TAKEN OUT AND GOT A PUMP IMPLANTED. THE PATIENT ENTIRE SYSTEM WAS REMOVED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414942 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention