BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 11596933 · Received March 31, 2021

    Report

    Report Number
    3004209178-2021-05266
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    September 23, 2020
    Report Date
    March 31, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109513
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977C165, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977C165, SERIAL/LOT #: (B)(4), UBD: 29-JUN-2020, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WHILE SHE WAS IN THE HOSPITAL AFTER HER QUADRICEPS SURGERY SHE TRIED TO TURN THE IMPLANTED NEUROSTIMULATOR  (INS) ON BECAUSE SHE WAS HAVING PAIN IN HER BACK AND LEGS AND SAW THE END REPLACEMENT INDICATOR (ERI) MESSAGE (B)(6) 2020 - PT WAS ABLE TO TURN STIM ON.  THEY ALSO STARTED HAVING "STOMACH ISSUES / ACHES" SINCE MID- (B)(6) 2020.  THEY CALLED THEIR IMPLANT HEALTHCARE PROVIDER (HCP) ABOUT ERI MESSAGE.  THE PATIENT'S DOCTOR TOLD HER TO TURN THE INS OFF.   ON (B)(6) 2020, THEY SAW THE END OF SERVICE (EOS) CODE ON THEIR PROGRAMMER, AND THEY COULDN'T TURN STIM ON.  PATIENT SERVICES (PSS) SUGGESTED THE PATIENT CONNECT WITH HER HCP TO DISCUSS REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT AND IT WAS REPORTED THAT THEIR SPINAL CORD STIMULATION (SCS) BROKE AND HAD TO HAVE IT EXPLANTED. PT SAID WHEN THEY HAD THEIR KNEE REPLACED (FELL AND HAD RUPTURED QUAD TENDON), IN SURGERY THEY LIFT LEG UP REALLY FAR TO MAKE SURE IT CAN BEND- PT THINKS THAT MOVED A LEAD OUT OF PLACE ("PULLED A WIRE OUT OR SOMETHING"). WHEN THE PT WENT TO TURN THEIR SCS ON AFTER SURGERY, THEY SAID THEY SAW EOS ON THEIR SCREEN. PT SAID THIS ALL HAPPENED IN (B)(6) 2020 (PT SAID SURGERY WAS ON (B)(6). PT MENTIONED THEY COULDN'T HAVE THE SCS TAKEN OUT FOR 6 MONTHS BECAUSE THEIR LEGS WAS IN A CAST AND THEIR HCP DIDN'T THINK THEY WOULD BE ABLE TO LAY ON THEIR STOMACH COMFORTABLY TO HAVE THEIR INS REMOVED AT THAT TIME. PT HAD THE SCS TAKEN OUT 6 WEEKS AGO (PT CONFIRMED LEADS AND IMPLANT REMOVED). PT SAID THEY HAD TO GET A LAMINECTOMY TO GET THE LEADS OUT BECAUSE THERE WAS TOO MUCH SCAR TISSUE. WHEN THE PT HAD THE SCS TAKEN OUT, PT SAID THEY DID NOT NOTICE MUCH DIFFERENCE THAN WHEN THEY HAD IT ON ALL OF THE TIME. PT SAID THEY HAD THE SCS STIMULATION ON ALL OF THE TIME SINCE THEY HAD IT IMPLANTED BECAUSE THEY WERE AFRAID THEY WERE GOING TO HAVE CRAZY NERVE PAIN BUT WHEN THE DEVICE SHUT ITSELF OFF, THEY DID NOT NOTICE A DIFFERENCE (PT MENTIONED THEIR DOCTOR THINKS THEIR NERVE WAS STARTING TO CALM DOWN AND THEIR BRAIN JUST GOT USED TO IT). PT SAID WHEN THEIR LEG HURTS NOW AFTER THEY'VE HAD THE SCS REMOVED, THEIR HCP SAID TO JUST UP THEIR PAIN PILLS BY 10MG- JUST UP IT BY 5S AND TAKE A BENADRYL AT NIGHT AND WHEN THEY WAKE UP IN THE MORNING THEY ARE USUALLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491094 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702 00643169109513

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention