BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 8960722 · Received September 4, 2019

    Report

    Report Number
    3004209178-2019-16943
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Report Date
    September 4, 2019
    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
    MI, 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 FROM A PATIENT VIA A MANUFACTURER REPRESENTATIVE (REP). THE PATIENT WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVER DISCHARGED DUE TO THE PATIENT NOT CHARGING THE INS FOR AT LEAST SIX MONTHS. IT WAS NOTED THAT ANOTHER REP WAS POTENTIALLY MEETING WITH THE PATIENT TO ADDRESS THE OVER DISCHARGE. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT AND IT WAS UNKNOWN IF SURGICAL INTERVENTION WAS PLANNED. THERE WERE NO REPORTS OF MEDICAL OR THERAPY ISSUES AND NO PATIENT SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) ON 2019-AUG-27 INDICATING THAT A CLINICAL SPECIALIST MET WITH THE PATIENT ON (B)(6) 2019 AND WAS ABLE TO RESOLVE THE OVER DISCHARGED INS AND CLEAR THE POWER ON RESET (POR). ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 2019-AUG-29. THE PATIENT CALLED SAYING THEY WANTED TO MEET UP BECAUSE THE BATTERY WAS TURNING ON AND OFF FOR NO REASON. IT WAS UNKNOWN IF THERE WERE ANY CAUSES. THE REP WAS MEETING WITH THE PATIENT TODAY TO ASSESS. THE ISSUE WAS NOT RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 2019-AUG-30. THE REP MET UP WITH THE PATIENT WHO COMPLAINED OF THE SYSTEM TURNING OFF UNEXPECTEDLY BUT THE REP COULD NOT SEE ANYTHING IN THE DIARY THAT INDICATED THAT. THE POR WAS RECENTLY CLEARED, SO THERE WAS VERY LITTLE DATA ON THE DEVICE. CURRENT USAGE INDICATES LESS THAN 1%. THE PATIENT ALSO COMPLAINED OF CHARGING EVERY OTHER DAY. THE BATTERY DIARY INDICATED THAT THE PATIENT WAS CHARGING EVERY 2 TO 3 DAYS. THE REP WAS NOT SURE IF THIS IS RELATED TO SOME DAMAGE THAT OCCURRED TO THE SYSTEM BECAUSE OF BEING OVER DISCHARGED. THE PATIENT¿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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754272 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1