BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3973892 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13858
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 11, 2014
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CHANGE IN STIMULATION LOCATION. IT WAS ALSO NOTED THAT THERE WAS STIMULATION IN THE WRONG LOCATION. THE PATIENT STATED THAT THE ISSUE BEGAN (B)(6) WHEN SHE WENT BACK TO WORK. THE PATIENT NOTED THAT SHE WENT BACK TO WORK TWO WEEKS PRIOR TO REPORT. THE PATIENT NOTED THAT IT ¿SEEMED TO BE HITTING THE SPOT THAT SHE NEEDED IT TO BUT NOW IT SEEMED LIKE IT WAS NOT HITTING THE SPOTS ANYMORE.¿ THE PATIENT STATED SHE TOOK TWO DAYS OFF OF WORK AND THEN WENT BACK TO WORK ON ¿MONDAY¿ AND THE FIRST DAY WAS OKAY. IT WAS NOTED THAT IT WAS SORE BUT MANAGEABLE AND THERE WERE NO SHARP STABBING PAIN. THEN PATIENT NOTED THAT ¿TUESDAY¿ SHE STARTED TO HAVE ¿SHARP STABBING PAINS¿ AGAIN IN THE BACK. THE CALLER WAS ASKED IF THIS WAS GRADUAL OR SUDDEN. THE PATIENT REPLIED THAT IT WAS HARD TO SAY AND IT HAPPENED WITH ACTIVITY. THE PATIENT STATED THAT THE STABBING PAIN WAS NOT GRADUAL. THEN THE PATIENT STATED, ¿BUT THEN WEDNESDAY AFTER WORK IT WAS JUST UGH ¿ IT WAS NOT HITTING THE SPOTS THAT IT USED TO BE HITTING.¿ THE PATIENT ASKED FOR HELP WITH REPROGRAMMING AND REQUESTED AN APPOINTMENT WITH THE MANUFACTURER REPRESENTATIVE. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROFESSIONAL (HCP). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450987 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR