BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 10287433 · Received July 17, 2020

    Report

    Report Number
    3004209178-2020-12353
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    January 30, 2017
    Report Date
    July 16, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM A CONSUMER REGARDING A PATIENT WHO IS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE DEVICE ZAPS AND JOLTS THE PATIENT AND DOES NOT HELP HER PAIN. THE PATIENT DOES NOT LIKE THE STIMULATION SENSATION AND JOLTING. THERE WERE NO EXTERNAL CONTRIBUTING FACTORS NOTED. REPROGRAMMING WAS ATTEMPTED, BUT THE PATIENT DID NOT WANT TO TRY THE NEW PROGRAMS. THE PATIENT HAS DECIDED THAT SHE WANTS THE SYSTEM EXPLANTED. THE ISSUE WAS NOT YET RESOLVED AT THE TIME OF THE REPORT. SURGICAL INTERVENTION HAS BEEN PLANNED BUT HAS NOT BEEN SCHEDULED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755377 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention