BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4824393 · Received June 8, 2015

    Report

    Report Number
    3004209178-2015-10417
    Event Type
    Injury
    Date Received
    June 8, 2015
    Report Date
    May 15, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL REVIEW IT WAS DETERMINED THIS EVENT WAS A SERIOUS EVENT BUT NOT LIFE THREATENING.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: 2015 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 97791, LOT# N504948, IMPLANTED: 2015 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE DOCTOR¿S OFFICE REPORTED THAT THE STIMULATOR HAD NOTHING TO DO WITH THE DEPRESSION AND IT DID NOT CAUSE THE DEPRESSION. AS FAR AS THE ANEURYSM WAS CONCERNED, THE DOCTOR WAS NOT AWARE OF THAT BUT IT HAD NOTHING TO DO ALSO WITH THE STIMULATOR. THE PATIENT WAS AT THE DOCTOR¿S OFFICE 3 DAYS PRIOR, ON (B)(6) 2015, AND WAS ASKED IF SHE WANTED TO COME IN AND SEE THE DOCTOR FOR THE ANEURYSM SINCE IT WAS A DIFFERENT MATTER TO WHEN SHE CAME IN FOR HER STIMULATOR. THE PATIENT WAS GOING TO THINK ABOUT IT BECAUSE HER FILMS WERE SOMEWHERE ELSE. IT WAS NOTED THAT THE PATIENT HAD SEEN THEIR PSYCHIATRIST THERE, AND THE PATIENT WANTED TO CONTINUE PSYCHIATRIC CARE WITH THEM. 4 DAYS LATER ON (B)(6) 2015, THE PATIENT REPORTED THAT SHE STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY BUT SHE WAS WORKING WITH HER DOCTOR OR MANUFACTURING REPRESENTATIVE (REP). AN APPOINTMENT DATE WAS SET FOR ¿ (B)(6) 2015.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BRAIN ANEURYSM THAT PRE-EXISTED THE IMPLANT, BUT IT WORSENED AT A POINT AFTER IMPLANT. THE PATIENT¿S DEPRESSION HAD INCREASED. THE PATIENT INQUIRED ABOUT AN EXPLANT. 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
    367547 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O