BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5115092 · Received September 30, 2015

    Report

    Report Number
    3004209178-2015-19093
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Report Date
    September 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97792, LOT# N507593, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT ALL X-RAYS AND IMPEDANCE CHECKS SHOWED THE DEVICE TO BE WORKING NORMALLY AND THE LEADS APPEARED TO BE IN THE SAME POSITION AS AT INITIAL IMPLANT. IMPEDANCES RESULTS INDICATED THERE WERE NO OPENS, NO SHORTS, AND THE RANGE PROVIDED WAS 760-961 OHMS. THE PATIENT'S ISSUES HAVE CONTINUED; THE PATIENT WAS GETTING RIB STIMULATION AND WAS NOT RECEIVING COVERAGE WHERE IT WAS NEEDED. THE MANUFACTURER REPRESENTATIVE FELT LIKE THEY HAD EXHAUSTED EVERY OPTION. FURTHERMORE, THE MANUFACTURER REPRESENTATIVE HAD MET WITH THE PATIENT OVER 20 TIMES AND THE LAST TIME THEY MET, THE MANUFACTURER REPRESENTATIVE TRIED EVERY BIPOLE OPTION AVAILABLE AND COULD NOT GET PROPER COVERAGE. THEY HAVE TRIED HIGH DENSITY (HD) PROGRAMMING AS WELL. IT WAS NOTED THAT WHEN TESTING BIPOLES, THEY DID NOT NECESSARILY LINE UP ANATOMICALLY WITH WHAT THE MANUFACTURER REPRESENTATIVE WOULD HAVE EXPECTED TO SEE (I.E. ONE ELECTRODE COMBINATION WOULD BE EXPECTED STIMULATE THE LEFT, BUT THE RIGHT SIDE WAS STIMULATED). SYSTEM REMOVAL WAS BEING CONSIDERED. IT WAS ALSO REPORTED THAT THE PATIENT'S CONDITION IS SUCH THAT SHE FELL A LOT, BUT THIS ISSUE WAS NOT ATTRIBUTED TO ONE SPECIFIC FALL. IT WAS CLARIFIED THAT THE PREVIOUSLY REPORTED "SECONDARY GAIN ISSUES" SUGGESTED, THE PATIENT MAY HAVE BEEN MOTIVATED TO PROLONG HER TREATMENT FOR OTHER REASONS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT ALL COMBINATIONS OF PROGRAMMING GAVE THE PATIENT RIB AND ABDOMINAL STIMULATION; NO PROGRAMMING PARAMETERS COULD CREATE LEG OR BACK STIMULATION. THE PATTERNS OF RIB STIMULATION "DID NOT SEEM ANATOMICAL." FOR EXAMPLE, +7/ -0 GAVE RIGHT RIB STIMULATION, +7/-2 GAVE RIGHT RIB STIMULATION, +7/ -1 GAVE LEFT RIB STIMULATION, AND +7/-3 GAVE LEFT RIB STIMULATION. THE CONSUMER REPORTED THAT THE DEVICE USED TO WORK WELL, BUT SHE HAD FALLEN MULTIPLE TIMES AND NOW SHE WOULD ONLY GET RIB STIMULATION. DIAGNOSTIC TESTING OR TROUBLESHOOTING PERFORMED INCLUDED X-RAYS; X-RAYS SHOWED THE LEAD POSITION AT MIDLINE AT THE T7-T8 LEVELS. THERE DID NOT APPEAR TO BE A LEAD MIGRATION. ACTIONS TAKEN TO RESOLVE THE ISSUE INCLUDED ATTEMPTING TO REPROGRAM THE DEVICE AND IMPEDANCE CHECKS THAT WERE NORMAL. IT WAS NOTED THAT THE ISSUE WAS NOT RESOLVED AT THE INITIAL TIME OF REPORT. THE HEALTHCARE PROFESSIONAL REPORTED THAT THE LEAD POSITION WAS NORMAL, AND MOVING THE LEAD WOULD NOT IMPROVE THE PATIENT'S OUTCOME SINCE THE LEAD WAS ALREADY IN THE IDEAL PLACE. SINCE THE RIB STIMULATION DID NOT FOLLOW A PREDICTABLE ANATOMIC PATTERN, THE HEALTHCARE PROFESSIONAL FELT THAT THE PATIENT MAY HAVE HAD SECONDARY GAIN ISSUES. SURGICAL INTERVENTION WAS NOT PLANNED OR SCHEDULED. NO OUTCOME WAS REPORTED FOR THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT. THE PATIENT'S INDICATIONS FOR USE INCLUDED NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THE PATIENT WAS FEELING STIMULATION IN THE RIBS AND ABDOMEN WHEN SHE SHOULD HAVE BEEN FEELING STIMULATION IN HER LEGS AND LOWER BACK. ELECTRODE AND THERAPY IMPEDANCES WERE TAKEN AND ALL SHOWED WITHIN THE NORMAL RANGE IN THE HIGH 3 DIGITS. SEVERAL REPROGRAMMING SESSIONS WERE TRIED AND THEY HAD TRIED ALL THE ELECTRODES ON THE LEAD. BI-POLE PAIRS WERE TRIED ON EACH END OF THE LEADS. AN X-RAY OF THE SYSTEM WAS TAKEN AND IT SHOWED THE LEAD WAS EXACTLY THE RIGHT LOCATION FROM WHEN IT WAS FIRST PLACED. THE CONNECTIONS ALSO LOOKED GOOD. THE PATIENT WAS GETTING GOOD STIMULATION UNTIL A FEW MONTHS AFTER INITIAL SURGERY. THE ABDOMINAL AND RIB STIMULATION WAS NOT POSITIONAL AND STOPPED WHEN THE STIMULATION WAS OFF. THE PATIENT FELT STIMULATION BOTH ON THE LEFT RIB AND RIGHT DEPENDING ON THE ELECTRODES PROGRAMMED. THERE WAS NO PATTERN TO THIS. HISTORICAL IMPEDANCES WERE NOT AVAILABLE. IT WAS NOTED THE PATIENT HAD SEVERAL FALLS, BUT DID NOT KNOW WHEN THIS OCCURRED. A FALL COULD HAVE BEEN RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644749 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR