BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3782594 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08325
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7435, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7 48910, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3093-33, LOT# V266474, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-33, LOT# V260716, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT APPOINTMENT DATE (B)(6) WAS NOTED. BY THE STATEMENT: THE PATIENT WAS HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE, IT WAS NOTED "MAYBE" WITH A QUESTION MARK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION. IT WAS ALSO NOTED THAT THE PATIENT'S LEFT HIP WAS SORE AND THAT IS THE SAME SIDE IN WHICH HER IMPLANTABLE NEUROSTIMULATOR (INS) IS PLACED. THE PATIENT DID BUMP INTO THINGS ALL THE TIME. THE PATIENT HAD LOST ABOUT 30LBS, DOWN FROM (B)(6) AND AS A RESULT HER HIP WASN'T AS SORE. IT WAS NOTED THAT THE SYMPTOMS OCCURRED FOLLOWING A FALL. THE PATIENT FALLS DOWN QUITE A FEW TIMES. THE PATIENT WAS TOLD THE BATTERY WOULD LAST 10 YEARS. THE LAST TIME THE PATIENT SAW HER PREVIOUS PHYSICIAN WAS IN 2009-2010. THE PATIENT WAS SCHEDULED TO SEE NEW HCP (HEALTHCARE PROVIDER) LATER IN (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260584 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V-NP

    Patients

    Seq Age Sex Outcome Treatment
    1