BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4153218 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18561
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 18, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEADS (S/N (B)(4)), FOUND THAT THE CONDUCTORS ON THE LEAD BODIES WERE BROKEN 17.5 CM FROM THE DISTAL END.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD INTERMITTENT STIMULATION IN THE BACK AND LEG, LOSS OF STIMULATION, AND LOSS OF THERAPEUTIC EFFECT (LESS THAN 50% THERAPY RELIEF) THAT WAS REPORTED ON THE MORNING OF THE REPORT. IT WAS STATED THAT THE LOSS OF STIMULATION AND THERAPEUTIC EFFECT WAS SUDDEN. IT WAS STATED THAT IMPEDANCE TESTING WAS PERFORMED AND THE PATIENT¿S DEVICE WAS REPROGRAMMED. IT WAS STATED THAT ELECTRODE IMPEDANCE WAS RUN WHILE THE PATIENT SAT UPRIGHT, LEANING FORWARD, LEANING BACK, AND TO THE LEFT AND RIGHT SIDES. IT WAS NOTED THAT THERE WAS INCONSISTENCY IN POSITIONS: ARCHED BACK 3 4 12 15. LEAN RIGHT 3 4 12 14 15 LEAN LEFT 3 4 14 15 LEAN FORWARD 3 4 11 12 14 15 IT WAS STATED THAT THE PATIENT WAS REPROGRAMMED AROUND THE OOR (OUT OF RANGE) ELECTRODES AND THE PATIENT FELT COVERAGE IN THE AREAS HE NEEDED IT. IT WAS STATED THAT THE PATIENT HAD NO FALLS. IT WAS STATED THAT THE PATIENT WAS GETTING GOOD STIMULATION WHEN REPROGRAMMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER THE PATIENT HAD THE REVISION, HE WAS DOING FABULOUS AT HIS POST OP TODAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S LEAD REVISION WENT WELL THE DAY PRIOR. THE PATIENT GOT GOOD COVERAGE POST-OP AND FELT TINGLING WHERE HE NEEDED IT. THE LEADS WERE TO BE SENT BACK TO THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WISHED TO HAVE A REVISION. THE REVISION WAS SCHEDULED FOR (B)(6) 2014. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN APPOINTMENT WAS SET ON (B)(6) 2014 FOR THE MANUFACTURING REPRESENTATIVE AND THE PATIENT AT THE HEALTHCARE PROVIDER'S (HCP) OFFICE TO GET A REPORT OF ELECTRODES. IT WAS NOTED THAT THE SPINAL CORD STIMULATOR (SCS) STILL "CUTS IN AND OUT. "THE PATIENT MOVED BACK TO MANUEL MODE TODAY, AND WANTED THE LEADS REVISED BUT WAS STILL USING IT AS IT STILL HELPED SOME. AT THE APPOINTMENT, THE PATIENT WAS GIVEN A PROGRAM WITH SOME ELECTRODES THAT WOULD GIVE HIM STIMULATION UNTIL THE REVISION WAS APPROVED. THE PATIENT WAS DOING WELL AT THE TIME OF LEAVING THE HCP OFFICE. NO REVISION HAD BEEN SCHEDULED YET. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630591 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention