BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 8682480 · Received June 10, 2019

    Report

    Report Number
    3004209178-2019-11185
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 9, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER (CON). IT WAS REPORTED THAT THE PATIENT NOTICED THE STIMULATOR WASN¿T WORKING THREE WEEKS PRIOR. THEY STATED THAT THE CIRCUMSTANCES THAT LED TO IT NOT WORKING WAS IT WAS IN THE WRONG LOCATION; TOO HIGH. NOTHING WAS DONE TO RESOLVE THIS AND THE PATIENT¿S DOCTOR SAID THERE WAS NOTHING THEY COULD DO.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE STIMULATOR WAS NOT WORKING. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476312 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR