BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6407578 · Received March 15, 2017

    Report

    Report Number
    3004209178-2017-05675
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 17, 2017
    Report Date
    March 15, 2017
    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
    IN, US
    Reporter Occupation
    OTHER

    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 FROM A CONSUMER VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAS BEEN WORKING A LOT LATELY, MEANING THEY ARE ON THEIR FEET A LOT AT WORK. THE PATIENT REPORTED PAIN IS PRETTY BAD IN THEIR LEFT FOOT. THE REP OFFERED TO ADJUST THE PATIENT'S STIMULATION, WHERE THEY ADDED A SINGLE BI-POLE AT THE TOP OF LEFT LEAD 90/1000. AT 9.9 AMP THE PATIENT DOES NOT FEEL STIMULATION WHEN SITTING UPRIGHT, THE PATIENT FEELS STIMULATION SLIGHTLY WHEN LYING DOWN. THE PATIENT WAS INSTRUCTED THAT THE NEW SETTINGS WILL REQUIRE MORE FREQUENT CHARGING AND THEY NEED TO WATCH BATTERY DEPLETION CLOSELY THROUGH THE WEEKEND. THE PATIENT VERBALIZED UNDERSTANDING. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189436 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR