BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5314409 · Received December 21, 2015

    Report

    Report Number
    3004209178-2015-25346
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Report Date
    December 1, 2015
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE PATIENT WAS GOING TO HAVE A BONE DENSITY, MAMMOGRAM AND ULTRASOUND. THE PATIENT ALSO REPORTED THE STIMULATION VIBRATED IN THE UPPER BODY WHEN LYING DOWN. IT WAS NOTED THE PATIENT COULD NOT LAY DOWN WITH IT ON. SHE WAS NOT PROGRAMMED FOR LYING DOWN. IF SHE LIED DOWN, IT VIBRATED QUITE A BIT TO HER UPPER BODY. THE PATIENT SAID SHE DID NOT HAVE IT ON DURING THE NIGHT; SHE TURNED IT ON DURING THE DAY. THE PATIENT STATED, THEY WANTED TO REPROGRAM FOR LYING DOWN BUT THE PATIENT DID NOT WANT THEM TO. RELEVANT MEDICAL HISTORY INCLUDED SPINAL PAIN. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842189 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1