BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5359380 · Received January 11, 2016

    Report

    Report Number
    3004209178-2016-00370
    Event Type
    Injury
    Date Received
    January 11, 2016
    Report Date
    December 18, 2015
    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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEURO STIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS GETTING AN OCCASIONAL BURNING SENSATION AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET INCISION AREA AND IT WAS HAPPENING MORE OFTEN AND ONLY WHEN IT WAS ON. THE INS MOVED AN INCH OR SO AND THEY DID NOT KNOW THE CAUSE. IT WAS UNKNOWN WHAT WAS CAUSING THE ISSUE BECAUSE NO DIAGNOSTICS HAD BEEN PERFORMED YET. THE ISSUE WAS NOT RESOLVED AND A FOLLOW UP WAS PLANNED FOR MONDAY. THE PATIENT WAS ADVISED TO TURN THE STIMULATOR OFF FOR NOW. NO SURGICAL INTERVENTION OCCURRED AND NONE WAS PLANNED. IT WAS LATER REPORTED THAT THE INCISIONAL AREA WAS PAINFUL AND BURNING EVEN WHEN THE STIMULATOR WAS OFF, NOW THAT SHE HAD IT OFF ALL WEEK. HER BACK PAIN FROM HER ARACHNOIDITIS HAD BEEN WORSE WITHOUT THE STIMULATOR ON. A REP WAS GOING TO MEET WITH THE PATIENT ON (B)(6) 2015 TO HELP DETERMINE THE CAUSE IF POSSIBLE. AN IMPEDANCE CHECK AND TROUBLESHOOTING WERE PLANNED. THE ISSUE WAS NOT RESOLVED AND THE PAIN WAS PERSISTING. AT THE APPOINTMENT IMPEDANCE CHECK SHOWED 0 OK, AND GROUP C IMPEDANCE WAS 321 OHMS, 6.456 MA, AND 8 ELECTRODES BEING USED IN PROGRAMMING 4+,4. PER HUSBAND THE INCISION SITE LOOKED PINK 3 DAYS AGO. THE DOCTOR STATED IT LOOKED FINE, NO FLUID LEAKING FROM THE SITE, AND NO FLUID PRESENT AROUND THE DEVICE. THE INS WAS CONFIGURED 4-5-6+ 7+11-12-13+14+. IMPEDANCES PROVIDED TODAY: 4/5 = 962, 4/6 = 1200 4/7 = 1110, 5/6 = 1068, 5/7 = 1071, 6/7 = 1050, 11/12 = 1177, 11/13 = 1256, 11/14 = 1365, 12/13 = 1028, 12/14 = 1456, AND 13/14 = 947. THE PATIENT TURNED STIMULATION ON TODAY BECAUSE HER PAIN RETURNED DUE TO THE INS BEING SHUT OFF. SIX WEEKS AGO THE PATIENT STARTED AN EXERCISE CLASS WHERE THERE WAS SOME TWISTING, AND FOLLOWING THAT CLASS WAS WHEN SHE NOTICED THE SUDDEN BURNING SENSATION. THE PATIENT WAS GETTING EXCELLENT THERAPY AND RELIEF FROM THE STIMULATION FOR BACK COVERAGE. THERE WAS NO REPORT OF A FALL OR TRAUMA. THERE WERE GOING TO FURTHER DISCUSS WITH THE HEALTHCARE PROFESSIONAL (HCP) IF X-RAYS WERE NEEDED. THE REP LATER SPOKE WITH THE HCP AND HE DID NOT FEEL AN X-RAY TO EVALUATE THE LEAD AND INS WAS INDICATED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17366 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Other