BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3890693 · Received June 24, 2014

    Report

    Report Number
    3004209178-2014-11956
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 9, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT A CANDIDATE FOR ADDITIONAL SURGERY. THE PATIENT WAS REFERRED TO A PAIN MANAGEMENT PHYSICIAN FOR ADDITIONAL INJECTIONS OR ABLATIONS BUT THE PATIENT COULD NOT REMEMBER WHICH. THE PATIENT SCHEDULED AN APPOINTMENT AND THEN CANCELLED IT BECAUSE THEY DIDN'T THINK IT WAS GOING TO WORK. THE PATIENT HAD ALSO CANCELLED A FEW DIFFERENT REPROGRAMMING APPOINTMENTS. THE PATIENT HAD BEEN SEEN A TOTAL OF 4 TIMES SINCE THE IMPLANT INCLUDING THE POST-OP APPOINTMENT AND MOST APPOINTMENTS WERE FAIRLY CLOSE TO THE TIME OF THE IMPLANT. THE PATIENT NEVER TURNED THEIR STIMULATION OFF AS IT WAS HELPING A LITTLE WITH THEIR NERVE AND LEG PAIN. THEY HAD BEEN UNABLE TO REPRODUCE THE >50% PAIN RELIEF THAT THE PATIENT EXPERIENCED DURING THE TRIAL DESPITE USING A LAMINECTOMY LEAD AND HAVING THE STIMULATION COVERAGE IN MOST AREAS OF THE PATIENT'S PAIN. THE PATIENT WAS ANGRY AND FELT THAT THE ENTIRE EXPERIENCE HAD BEEN A MAJOR LET DOWN. THE IMPLANTABLE NEUROSTIMULATOR (INS) IN THE PATIENT'S LEFT ABDOMEN HAD BEEN FLIPPING OVER. THE PATIENT THOUGHT THAT THEIR DOCTOR IMPLANTED THE WRONG DEVICE SINCE THE PATIENT WANTED A RECHARGEABLE INS. IT WAS FURTHER REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD NOT SPOKEN TO THE PATIENT SINCE (B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED HER THERAPY WASN'T DOING ANYTHING FOR HER. IT WAS NO LONGER MEETING HER EXPECTATIONS. THE PATIENT CANCELLED A REPROGRAMMING SESSION AND DECLINED FURTHER SESSIONS. THE PATIENT HAD GOOD RELIEFUPON IMPLANT AND WAS HAPPY WITH THE PROGRAMMING. THE PATIENT WAS SEEN FOR ROUTINE ADJUSTMENTS THE WEEK PRIOR AND WAS HAPPY WITH IT, AS MORE AREAS WERE CAPTURED. THE IMPLANT WAS FUNCTIONING NORMALLY, ALL IMPEDANCES WERE NORMAL. THE PATIENT WAS JUST DISSATISFIED WITH THERAPEUTIC BENEFIT. IT WAS FURTHER REPORTED THAT THEY PATIENT HAD BEEN ADJUSTING THEIR DEVICE UP AND DOWN. THEY INDICATED THE DEVICE FUNCTION HAD NOT ADVERSELY CHANGED. IT WAS FURTHER REPORTED THAT IT TOOK 6-8 WEEKS FOR THE PATIENT'S INS POCKET SITE TO HEAL. THE PATIENT WASN'T REAL HAPPY WITH THE STIMULATION. THE PATIENT NOTED THAT IT HELPED SOME BUT IT WAS DISAPPOINTING. THE PATIENT'S STIMULATOR WAS MEANT TO TREAT THEIR LEFT LEG AND LOW BACK. THE STIMULATION DIDN'T GET UP INTO THEIR LOW BACK ENOUGH. THE PATIENT HAD HAD SEVERAL ADJUSTMENTS MADE. THE PATIENT STARTED HAVING THE ISSUE WITH THE STIMULATION NOT REACHING UP INTO THEIR LOW BACK A WEEK AFTER IMPLANT. THE PATIENT WAS TIRED OF HAVING ADJUSTMENTS AND THEY MIGHT JUST TAKE THE INS OUT. IT WAS FURTHER REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY AND HAD NOT SOUGHT FURTHER HELP. THE PATIENT HAD APPOINTMENTS ON THE DAY OF SURGERY AND 3 TIMES AFTER. THE PATIENT NOTED "ANYTHING SULFA IN WHERE IN DEVICE" BUT IT WAS UNCLEAR WHAT THIS MEANT. THE DEVICE WAS TURNING IN THE PATIENT'S STOMACH AND IT HURT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS GOING BACK FOR ADDITIONAL SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE MANUFACTURER REPRESENTATIVE SPOKE WITH THE PATIENT ON (B)(6) 2014. THE PATIENT DECLINED A MEETING TO ADJUST HER PROGRAMMING OR TO CHECK THE BATTERY CAPACITY. THE PATIENT WAS TO GO TO (B)(6) SOON FOR INJECTIONS FOR PAIN. THE PATIENT COULD NOT REMEMBER WHEN OR WHAT THE INJECTIONS WERE. THE PATIENT STATED SHE USED STIMULATION 24/7 BUT GETS NO PAIN RELIEF. WHEN ASKED HOW THE PAIN WAS WHEN SHE TURNED THE DEVICE OFF, THE PATIENT STATED SHE CANT TURN IT OFF BECAUSE THE PAIN WOULD COME BACK. WHEN AGAIN QUESTIONED IF SHE WAS GETTING PAIN RELIEF SHE STATED SHE WAS NOT. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368144 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention