BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3854150 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10269
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    July 17, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; 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).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A PROBLEM WITH THE PATIENT PROGRAMMER AND WAS NOT ABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT THE ANTENNA ATTACHED. A COMMUNICATION PROBLEM WAS REPORTED. IT WAS STATED THAT THE PATIENT WAS CHARGING LAST WEEK, BUT HAD DIFFICULTY WITH GETTING COUPLING. IT WAS NOTED THAT ON ONE OF THE DAYS, HE GOT 4 COUPLING BARS FOR 6 HOURS. IT WAS STATED THAT THE PATIENT MET WITH HIS HEALTHCARE PROFESSIONAL (HCP) TO CHECK THE INCISION SITE 2 WEEK AGO, AND THE MANUFACTURER¿S REPRESENTATIVE WAS THERE TO MAKE SURE EVERYTHING WAS FINE WITH THE IMPLANT. IT WAS REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE TOLD HIM THE IMPLANT WAS IN SLEEP MODE. IT WAS STATED THAT THE USE OF ANTENNA LOCATE RESULTED IN A POR (POWER ON RESET) BEING DISPLAYED ON THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR), WHICH THEN LEAD TO THE NORMAL RECHARGING SCREEN. IT WAS NOTED THAT THE PATIENT WOULD CALL BACK LATER TO GET ASSISTANCE WITH CLEARING THE POR. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DISPLAY SHOWED A "CALL YOUR DOCTOR" ICON. IT WAS NOTED THAT THE CALLER WAS TOLD TO CALL BACK TO CLEAR POR BUT IT WAS A WARNING POR SO THE PATIENT SERVICES AGENT WAS UNABLE TO CLEAR THE POR FOR THE PATIENT. IT WAS STATED THAT THE PATIENT WAS RECHARGING AND GETTING TWO COUPLING BOXES. IT WAS STATED THAT HE TURNED THE ANTENNA DIAL AND THEN GOT FOUR BOXES. ADDITIONAL INFORMATION RECEIVED RESTATED ALLEGATIONS FROM PREVIOUS CALLS. IT WAS STATED THAT ¿I¿VE TALKED TO A FEW DIFFERENT GENTLEMEN AND I HAVE A POR ON MY RECHARGE AND THEY GOT IT STARTED AND IT WENT TO 6 BOXES, THEN 4, THEN 2, AND POPPED BACK ON POR AND HE SAID IT WAS A RED FLAG TO GET A HOLD OF MY DOCTOR¿. IT WAS FURTHER STATED THAT THE PATIENT¿S HCP COULDN¿T GET HIM IN UNTIL (B)(6) SO HE WAS ¿WORRIED THAT IF I WAIT THAT LONG THEN THE STIMULATOR WOULD GO BAD¿. IT WAS NOTED THAT THE PATIENT WAS REFERRING TO SPEAKING WITH PATIENT SERVICES, NOT MANUFACTURER¿S REPRESENTATIVES. IT WAS STATED THAT THE PATIENT HAD NEVER BEEN IN AN OVERDISCHARGED STATE BEFORE. IT WAS STATED THAT IT HAD ¿PROBABLY BEEN A WEEK¿ SINCE THE PATIENT LAST FELT STIMULATION AND LAST RECHARGED "THE WEEK PRIOR TO THAT¿. IT WAS STATED THAT HE THOUGHT HE WAS CHARGING, BUT HAD BEEN HAVING TROUBLE. IT WAS STATED THAT THE PATIENT HAD ¿BEEN TO THE HOSPITAL EVERY 2 WEEKS SINCE THIS ALL STARTED BECAUSE I HAVE HAD INCISION PROBLEMS SINCE THE IMPLANT; AND NOW IT WAS GOOD". ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WOULD BE SEEN BY A MANUFACTURER¿S REPRESENTATIVE THE UPCOMING FRIDAY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BOOKED FOR A ¿NURSE VISIT¿ TO BE SEEN BY A MANUFACTURER¿S REPRESENTATIVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE POR WAS RESET AND THE PATIENT WAS ABLE TO RECHARGE THE DEVICE. IT WAS STATED THAT HE WAS GETTING GREAT THERAPY. IT WAS REPORTED THAT THE PATIENT HAD TO RECHARGE THE DEVICE MORE FREQUENTLY, ABOUT EVERY 6 HOURS, DUE TO THIS BEING HIS 3RD OVERDISCHARGE.IT WAS STATED THAT THE PATIENT WAS GOING TO BE CONSULTED FOR A REPLACEMENT. IT WAS NOTED THAT THE MANUFACTURER'S REPRESENTATIVE HAD NOT HEARD ANYTHING ABOUT HIM AND DID NOT KNOW IF IT HAD BEEN SCHEDULED OR IF IT ALREADY HAD BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331572 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR