BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4947247 · Received July 28, 2015

    Report

    Report Number
    3004209178-2015-14218
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Report Date
    July 8, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED:(B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2015 CRTS (B)(4)(CON): NGE WITH POSITION (PATIENT HAD ADAPTIVESTIM). THE PATIENT INDICATED SHE USED TO HAVE A SITTING AND STANDING POSITION BUT NOW THE SETTING WAS THE SAME WHICH CHANGED IN (B)(6). STARTING IN (B)(6) STIMULATION STARTED TO INCREASE BY ITSELF WHEN THE PATIENT WAS IN THE SAME POSITION, BUT NOW WHILE IN THE STANDING POSITION, STIMULATION WOULD TURN ITSELF DOWN AND THE PATIENT WOULD HAVE PAIN AS A RESULT. IT WAS NOTED THE PATIENT WAS STANDING/SITTING WHEN THEY FELT THE CHANGE OCCUR AND WAS RELATED TO POSITIONAL MOVEMENT AND WAS OCCURRING DAILY. THE PATIENT STATED THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED DOWN STIMULATION AFTER 30 MINUTES OF BEING IN THAT POSITION. IT WAS VERIFIED THAT STIMULATION WAS ON, THE GROUP WITH ADAPTIVESTIM WAS TURNED ON, AND THE PATIENT PROGRAMMER (PP) WAS DISPLAYING THE CORRECT POSITION. THERE WERE NO FALLS OR TRAUMAS REPORTED. IT WAS NOTED THE PATIENT DID FALL INITIALLY AFTER IMPLANT BUT HER IMPLANT WAS WORKING FINE AFTER. 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
    491084 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1