BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6099953 · Received November 14, 2016

    Report

    Report Number
    3004209178-2016-23909
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 14, 2016
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT WHEN THE PATIENT WAS SITTING THE PATIENT PROGRAMMER SHOWED THAT THEY WERE LYING FLAT. WHEN THEY WERE LYING STILL IN BED, THEY DID NOT HAVE PAIN ALL THE TIME BUT THE IMPLANT NEEDED TO BE ON ALL OF THE TIME. THE PATIENT STATED THAT THEY WENT FROM 5.00V TO 5.90V. THE PATIENT STATED THAT CURRENTLY THEY WERE SITTING WITH THEIR LEGS CROSSED BUT THE DEVICE SHOWED THAT THEY WERE LYING FLAT. THE PATIENT WAS CURRENTLY IN PAIN WHEN SITTING. THE PATIENT STATED THAT THEY WERE SET TO SHOW UPRIGHT WHEN SITTING AND MOBILE WHEN STANDING. IT WAS FURTHER STATED THAT IT WAS EVEN SET TO WHERE WHEN THEY WERE LYING FLAT IT COULD HOW LYING LEFT AND LYING RIGHT BUT NOW WHEN THEY WERE SITTING IT SHOWED THEY WERE LYING FLAT. THE PATIENT STATED THAT THE HEALTH CARE PROFESSIONAL (HCP) SECRETARY HAD STATED THAT THE ISSUE MAY BE THE PATIENT PROGRAMMER. DURING THE CALL IT WAS CONFIRMED THAT THE STIMULATION WAS ON AND ADAPTIVE STIMULATION WAS ON. THE ISSUE WITH THE ADAPTIVE STIMULATION ISSUES STARTED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751030 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR