BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3964391 · Received July 29, 2014

    Report

    Report Number
    3004209178-2014-13627
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. 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. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37092, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO STIMULATION SENSATION. IT WAS NOTED THAT THE PATIENT STOPPED FEELING STIMULATION ONE DAY PRIOR TO REPORT. THE PATIENT TRIED TO USE THE PATIENT PROGRAMMER THE NIGHT PRIOR TO REPORT TO TURN ON THE IMPLANTABLE NEUROSTIMULATOR (INS) BUT WAS NOT ACQUIRING A CONNECTION. THE PATIENT STATED THERE WERE NO FALLS OR ACCIDENTS PRIOR TO THE FEELING OF STIMULATION STOPPING. IT WAS NOTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER. THE CALLER WAS NOT ABLE TO MAKE ADJUSTMENTS WITH OR WITHOUT THE ANTENNA. IT WAS FURTHER REPORTED THAT THE PATIENT PROGRAMMER WOULD NOT INTERROGATE. THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED A NEW PROGRAMMER BUT IT WAS DOING THE SAME THING AS THE OTHER PROGRAMMER. IT WAS NOTED THAT THE PATIENT OBSERVED THE ¿NO COMMUNICATION¿ SCREEN. THE PATIENT STATED HE JUST SPOKE TO ¿SOMEONE¿ ON THE DATE OF REPORT ABOUT HIS PROGRAMMER NOT WORKING AND RECEIVED A NEW ONE (B)(6) 2014. PATIENT SERVICES ASKED THE PATIENT TO UNPLUG THE ANTENNA AND THE PATIENT WAS THEN ABLE TO COMMUNICATE WITHOUT THE ANTENNA. THE PATIENT STATED HIS SETTINGS CAME UP ¿T 0.0.¿ PATIENT SERVICES TRIED TO HELP THE PATIENT INCREASE STIMULATION ON PROGRAM A BUT IT WAS NOT WORKING. THE PATIENT STATED HIS INS DOCTOR LIVED ABOUT AN HOUR AWAY AND SO HE WOULD SEE IF HIS GENERAL DOCTOR WOULD CALL A MANUFACTURER REPRESENTATIVE TO MEET AT THE DOCTOR¿S OFFICE. IT WAS NOTED THAT THE PATIENT PROGRAMMER/PTM ANTENNA WAS DAMAGED. IT WAS LATER REPORTED THAT THE NEW PATIENT PROGRAMMER AND ANTENNA WERE SHOWING THE SAME SCREEN AS THE INITIAL PATIENT PROGRAMMER. IT WAS NOTED THAT THERE WAS A DISPLAY SHOWING ¿IN THE BOX¿ ICON ON THE PATIENT PROGRAMMER. IT WAS NOTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT STATED HE WAS TOLD TO HAVE THE HEALTHCARE PROFESSIONAL (HCP) PAGE A MANUFACTURER REPRESENTATIVE BUT THE HCP WOULD BE AWAY FOR A ¿FEW WEEKS.¿ THE PATIENT ASKED FOR A MANUFACTURER REPRESENTATIVE TO VISIT THE MEDICAL FACILITY. THE PATIENT WAS REDIRECTED TO THE HCP. LATER THE SAME DAY, THE MANUFACTURER REPRESENTATIVE WROTE IN AND NOTED THAT THEY WOULD FOLLOW-UP WITH THE PATIENT AND THE DOCTOR¿S OFFICE TO GET THE PATIENT AN APPOINTMENT TO BE SEEN. ANALYSIS OF THE PATIENT PROGRAMMER FOUND THAT THERE WAS NO ANOMALY. 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
    441502 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR