BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6284037 · Received January 27, 2017

    Report

    Report Number
    3004209178-2017-01967
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    December 1, 2016
    Report Date
    June 1, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WORKED GREAT FOR 8-9 MONTHS BUT IN (B)(6) 2016 THEY STARTED TO HAVE PAIN IN THE CENTER OF THEIR BACK AND STIMULATION ABOVE THE BACK. THEY HAD NOT FELT THIS BEFORE. THE PATIENT STATED THEY FELT THE STIMULATION IN THE LEGS AND SIDES OF THEIR RIB CAGE. THEY REPORTED THAT THE STIMULATION WAS LESS AND LESS AND THAT IT WAS GOING TO AREAS OTHER THAN THE LOWER BACK (FELT THE STIMULATION IN THE ¿CENTER AND LEGS OF BACK¿) WHEREAS THEY DID NOT BEFORE. THE STIMULATION WAS AT 7.1 WHEREAS BEFORE IT WAS AT 6. THE PATIENT HAD NEVER FALLEN BUT DID MENTION WHEN PEOPLE SAID HI TO THEM THEY PATTED HIM ON THE BACK. THE PATIENT WAS NOT SURE IF THIS WAS RELATED TO THE ISSUE. THE PATIENT ALSO STATED THEY WERE NOT SURE IF THE LEADS HAD DISLODGED OR IF THE INS BATTERY NEEDED ¿TWEAKING.¿ ADDITIONAL INFORMATION WAS RECEIVED. MANUFACTURER REPRESENTATIVE REPORTED JOLTS AND SHOCKS THAT STARTED 45 DAYS AGO. IT WAS REPORTED THAT THE SHOCKING WAS RIGHT ABOVE T7 AT THE SITE OF THE LEAD. THESE EPISODES OCCURRED 1-4 TIMES A DAY AND THE PATIENT WAS NOT IN ANY PARTICULAR POSITION WHEN THIS OCCURRED. STIMULATION WAS STILL IN PATIENT'S LOWER BACK AND LEFT LEG, AS PRIOR TO FIRST REPORTED INCIDENT OF SHOCKING. IT WAS REPORTED THAT THERE WAS NO TRAUMA/FALLS THAT COULD HAVE BEEN RELATED, BUT IT WAS REPORTED THAT PEOPLE SLAP THE PATIENT IN THE BACK WHEN THEY GREET THEM. IMPEDANCE MEASUREMENTS WERE TAKEN: ELECTRODE 1-997 OHMS; 2-1016 OHMS; 3-1027 OHMS; 4-1036 OHMS; 5-1199 OHMS; 6-1000 OHMS; 7-1075 OHMS; 8-1060 OHMS; 9-1102 OHMS; 10-1073 OHMS; 11-1052 OHMS; 12-1105 OHMS; 13-1095 OHMS; 14-1104 OHMS; 15-1012 OHMS. NO CLEAR EVIDENCE AS TO THE CAUSE OF SHOCKING SENSATION WAS REPORTED. THE PATIENT AND MANUFACTURER REPRESENTATIVE WERE GOING TO FOLLOW-UP WITH THE PATIENT'S PHYSICIAN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER AND THE REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP RAN AN IMPEDANCE TEST AT .7 AND 3 VOLTS. THE 3 VOLT TEST SHOWED THAT THE IMPEDANCES WERE NORMAL ON ALL ELECTRODES. IT WAS CONFIRMED THAT THE ADAPTIVE STIMULATION WAS ACTIVATED. THE PATIENT REPORTED THAT THE PROGRAMS WERE PROVIDING PAIN RELIEF. THE REP RECOMMENDED THAT THE PATIENT KEEP A LOG OF WHEN THE EVENTS OCCUR. THE REP ALSO ASKED THE PATIENT TO REDUCE THE VOLTAGE AND SEE IF HE COULD STILL GET GOOD RESULTS IN TERMS OF PAIN RELIEF. IT WAS ALSO NOTED THAT A DETAILED MESSAGE WOULD BE PROVIDED TO THE PATIENT'S SURGEONS'S OFFICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT ON 2017-MAY-12. THE PATIENT STATED THAT THEIR IMPLANT DID NOT HELP MANAGE THEIR PAIN. THEY DID NOT KNOW WHAT STEPS WOULD BE TAKEN, THE ISSUE HAD NOT BEEN RESOLVED, AND THE MRI DID NOT SHOW ANYTHING WRONG WITH THE IMPLANT OR THERAPY. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A MRI ON (B)(6) 2017 TO SEE WHY THE PATIENT DOES NOT HAVE STRENGTH IN HIS LEGS. IT WAS ALSO NOTED THAT THEY MAY BE LOOKING AT HIS LEADS. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67040 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR