BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3841543 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09941
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 12, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED LAST WEDNESDAY AND HER SETTING WAS PUT ON 1.20. IT WAS REPORTED THAT STARTING SATURDAY, THE STIMULATION WAS TOO MUCH AND WAS IN HER RIGHT ARMPIT AND HAND. IT WAS REPORTED THAT ON SATURDAY, SHE ¿DECREASED THE SETTING TO 1.00 AND THEN DECREASED IT TO 1.70 WHEN SHE WENT TO BED¿. IT WAS REPORTED THAT TODAY, THE STIMULATION WAS SET AT 1.00 AND WAS NOT SO INTENSE BUT SHE COULD NOT INCREASE IT AT ALL OR IT WENT THROUGH HER ARMPIT AND HAND. IT WAS NOTED THAT THE IMPLANT WAS ¿ON HER LEFT SIDE BUT SHE WAS FEELING PAIN ON HER RIGHT SIDE IN THE MIDDLE OF HER BACK BY HER SPINE¿. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE CALLED THE PATIENT BACK ON HER OTHER LINE DURING THE CALL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE MET WITH THE PATIENT TUESDAY AND HER STIMULATOR WAS REPROGRAMMED AND THE HEALTHCARE PROFESSIONAL (HCP) GAVE A DIFFERENT PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317928 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR