BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3832887 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09622
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    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

    PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS AGO WHEN THE PATIENT WAS WALKING AND STANDING UP THEIR STIMULATION WAS SHUTTING OFF. IT WAS NOTED THE PATIENT HAD THEIR THERAPY AND STIMULATION ADJUSTED A WEEK AGO BY A MANUFACTURING REPRESENTATIVE. IT WAS FURTHER NOTED THE PATIENT WANTED TO MEET WITH A MANUFACTURING REPRESENTATIVE. THE REPORTER STATED THEY HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROFESSIONAL ON (B)(6) 2014. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A STIMULATOR IMPLANTED IN THE LOWER BACK FOR "CLOSE TO 3 MONTHS." IT WAS NOTED THAT THE ADAPTIVE STIMULATION (AS) HAD BEEN ACTIVATED "ROUGHLY 5 WEEKS AGO." IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD "JUST STOP WORKING FOR PERIOD OF TIME FOR NO REASON." IT WAS STATED THAT IT WOULD OCCUR MOSTLY WHEN THE PATIENT WAS WALKING AROUND A STORE OR "EVEN JUST A SHORT WALK IN [THE PATIENT'S] HOUSE. IT WAS NOTED THAT "SOMETIMES IT IS ONLY OFF FOR 5 SECONDS OR SO," WHILE OTHER TIMES "IT MAY BE A MINUTE OR TWO." IT WAS STATED THAT ADJUSTMENTS HAVE BEEN DONE, BUT HAVE FAILED TO WORK. IT WAS NOTED THAT THE PATIENT DID NOT WANT THE DEVICE IN HIS BACK IF IT WASN'T WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311708 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR