BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3172368 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10428
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    June 12, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REPROGRAMMED AND FELT BETTER. IT WAS STATED THAT THE HEALTHCARE PROVI DER (HCP) THOUGHT SHE HAD TENDONITIS AND WAS SCHEDULED FOR A BLOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE IMPEDANCE MEASUREMENTS THAT WERE GREATER THAN 10,000 OHMS ON ELECTRODE 3. IT WAS STATED THAT THE MANUFACTURER REPRESENTATIVE FIRST NOTICED THE ISSUE WHEN THEY SAW THE PATIENT APPROXIMATELY A YEAR AGO. IT WAS NOTED THAT THE LEAD WAS PLACE IN THE CERVICAL AREA AND ELECTRODE 3 WAS NOW USED IN PROGRAMMING. THERE WERE NO FALLS OR TRAUMA INDICATED, HOWEVER THE PATIENT REPORTEDLY HAD A ¿BIG SNEEZE¿ AND FELT SOMETHING CHANGE (APPROXIMATELY 2 YEARS AGO). IT WAS ADDED THAT REPROGRAMMING WAS DONE AND THE PATIENT NOW HAD TWO CATHODES AND ONE ANODE (PREVIOUSLY HAD ONE CATHODE AND ONE ANODE). ALSO, A LONGEVITY CALCULATION WAS PERFORMED FOR PREVIOUS SETTINGS (1.5 VOLT AMPLITUDE, 130 HERTZ FREQUENCY, 450 MICROSECOND PULSE WIDTH, CYCLING 5 MINUTES ON AND 30 SECONDS OFF, 12 HOUR PER DAY USAGE, THERAPY IMPEDANCE WAS NOT AVAILABLE) WITH A RESULT OF 62 MONTHS. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272794 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR