BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6034011 · Received October 17, 2016

    Report

    Report Number
    3004209178-2016-21900
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    July 4, 2016
    Report Date
    November 11, 2016
    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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THERE WAS STIMULATION IN AN UNDESIRED LOCATION. THE PATIENT NEEDS STIMULATION ACROSS HIS BACK AND GOING DOWN BOTH LEGS, BUT AT THE TIME OF THE REPORT HE WAS ONLY FEELING IT ON THE RIGHT SIDE LEG AND THAT THE PAIN STARTS IN HIS RIGHT HIP. THERE WAS NO FALL OR TRAUMA ASSOCIATED WITH THIS EVENT. THIS HAD STARTED OCCURRING ABOUT 2 TO 3 MONTHS PRIOR TO THE REPORT. THE PATIENT WAS REDIRECTED TO HIS HEALTH CARE PROVIDER. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) INDICATED THAT THE PATIENT FELT A HORRIBLE JOLT THAT CAUSED PAIN WHILE UNDER A CAR. THE PATIENT HAD TO GET THEIR WIFE TO GET THE REMOTE TO TURN STIMULATION OFF. THE HCP HAD TRIED UNSUCCESSFULLY TO PROGRAM SEVERAL DIFFERENT CONFIGURATIONS TO GET BETTER COVERAGE. THE DEVICE WAS PROGRAMMED WITH 1- 3+, 270US, 40HZ, A1 1041 2.891; 4+ 7- 270US 40HZ A2 860 3.463. THE PATIENT WAS FEELING STIMULATION IN THE MIDLINE ABDOMEN AROUND THE LAST RIB TO THE ILIAC CREST. THE WERE FEELING IT IN THE BACK TO THE ABDOMEN JUST BELOW THE NIPPLE LINE. PRIOR TO THE INCIDENT, THEY WERE GETTING STIMULATION IN THE LEGS. PROGRAMMING 6+ 7- THEY WERE FEELING STIMULATION IN THE RIGHT HIP REGION THROUGH TO THE LEFT SIDE AT 4.5V. 0+ 1- AT 3V THEY WERE FEELING STIMULATION IN THE LATERAL FLANK. IMPEDANCES MEASUREMENTS INDICATED ALL VALUES WERE 786-1200 OHMS EXCEPT 5, WHICH WAS 4900-4987 OHMS. THEY TOOK X-RAYS WHICH DID NOT SHOW ANY ISSUE, AND THE PADDLE LEAD APPEARED TO BE IN THE SAME POSITION AS AN X-RAY FROM 2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED THAT THE CIRCUMSTANCES THAT LED TO ONLY FEELING STIMULATION IN THE RIGHT SIDE LEG WAS UNKNOWN. AS OF (B)(6) 2016, THE PATIENT WAS WAITING FOR THEIR DOCTOR¿S INSTRUCTIONS FOR THE NEXT STEPS TO TAKE TO RESOLVE FEELING THE STIMULATION IN THE RIGHT SIDE LEG AND PAIN IN THE HIP. THE PAIN IN THE HIP HAD NOT BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686391 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97713

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR