BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3801947 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08773
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 10, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "FOR A WHILE" THE STIMULATION THERAPY HAD BEEN GOING "IN AND OUT." IT WAS REPORTED THAT THE PATIENT MENTIONED HAVING ISSUES TO THE MANUFACTURER'S REPRESENTATIVE WHEN SHE WAS PROGRAMMED "LAST SEVERAL MONTHS AGO." IT WAS NOTED THAT WITHIN THE PAST FEW DAYS IT HAD BEEN OCCURRING MORE OFTEN. IT WAS NOTED THAT THE PATIENT WOULD BE SITTING DOWN AND THE THERAPY WOULD "SHUT OFF AND THEN IT WOULD COME BACK ON" OR SHE WOULD BE STANDING AND IT WOULD STOP AND THEN SHE WOULD KEEP WALKING AND IT WOULD TURN BACK ON. THE PATIENT REPORTEDLY NOTIFIED THE MANUFACTURER'S REPRESENTATIVE THAT THE "THERAPY WAS NOT WORKING RIGHT SEVERAL MONTHS AGO." ADDITIONAL INFORMATION FROM THE PATIENT'S HEALTH CARE PROVIDER RECEIVED FIVE DAYS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN AND THAT NO INTERVENTION HAD OCCURRED. THE PATIENT WAS REPORTEDLY REPROGRAMMED FOR IMPROVED COVERAGE ON (B)(6) 2013 WITH NO COMPLAINT OF INTERMITTENT STIMULATION AT THAT POINT. THERE WAS REPORTEDLY NO HOSPITALIZATION NOR INJURY DUE TO THE EVENT. THE PATIENT REPORTEDLY CALLED THE OFFICE ON (B)(6) 2014 REPORTING NO PROBLEM WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) AND CANCELLED THE APPOINTMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT CANCELLED THEIR APPOINTMENT SO THEY WERE NOT SEEN BY A MANUFACTURING REPRESENTATIVE. THE REPORTER STATED THEY WERE MADE AWARE OF THE INTERMITTENT STIMULATION ON (B)(6) 2014, BUT THEY HAD NO SEEN THE PATIENT SINCE THEY CANCELLED THEIR APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281350 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR