BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4122554 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17815
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 3, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4). IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE IMPLANT THE PATIENT'S PROGRAMS HAD NOT HELPED WITH PAIN IN THE LEGS. WITH THE FIRST PROGRAM THE PATIENT FELT IT IN THEIR BLADDER AND THE SECOND PROGRAM THEY FELT IN THEIR DIAPHRAGM. THE PATIENT ALSO HAD A "HUGE BULGE" IN THEIR BACK WHERE THEY BELIEVED THE LEADS WERE LOCATED. THE SITE WAS PAINFUL AND SENSITIVE. WHENEVER THE PATIENT PUT ON PANTS OR LAID DOWN THE SITE WAS IRRITATED AND THEY COULD FEEL THE "COMPONENTS MOVING." THE PATIENT DID NOT HAVE ANY FALLS OR TRAUMA AND THEY DID NOT HAVE ANY NEW ACTIVITIES. THE PATIENT ALSO HAD A LOW GRADE FEVER, BETWEEN 99 AND 100 DEGREES SINCE THE IMPLANT. THE PATIENT HAD CONTACTED A MANUFACTURING REPRESENTATIVE THE MORNING OF THIS REPORT, BUT THEY HAD NOT HEARD BACK. NO INTERVENTIONS OR OUTCOME WERE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601029 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR