BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3324804 · Received September 4, 2013

    Report

    Report Number
    3004209178-2013-15610
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Report Date
    August 8, 2013
    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 MEDICAL PRODUCTS: PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010: PRODUCT TYPE: LEAD; PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009: PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009: PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT HAD NO STIMULATION SENSATION WHEN STIMULATION WAS RUN AT 10.5 V. IT WAS NOTED THAT THE SYMPTOMS OCCURRED FOLLOWING A FALL. IT WAS NOTED THAT THE PATIENT HAS HAD NUMEROUS FALLS. IT WAS NOTED THAT THE PATIENT LOST STIMULATION ABOUT 2 MONTHS AGO. IT WAS NOTED THAT THERE WAS NO PARTICULAR FALL RELATED TO THIS. IT WAS NOTED THAT INITIALLY THE REPORTER STATED THAT IMPEDANCES WERE NORMAL AND SHE COULD GET STIMULATION ON ELECTRODES 7/15. IT WAS FURTHER NOTED UPON INTERROGATION THE REPORTER STATED THAT THE PATIENT LOST STIMULATION AT THAT PAIR. IT WAS NOTED THAT CONTACTS 4/9 AND 9/14 WERE GREATER THAN 40,000 OHMS. IT WAS NOTED THAT THEY WERE NOT BEING USED IN PROGRAMMING. IT WAS NOTED THAT THE ONLY VIABLE PAIR WAS 1/7 BUT THAT GAVE THE PATIENT STOMACH STIMULATION REGARDLESS OF THE POLARITY USED. IT WAS NOTED THAT IMPEDANCES TAKEN AT 3.0V WITH 0 AS REFERENCE ELECTRODE WERE AS FOLLOWS: 1= 6221, 2= 11239, 3= 9857, 4= 15086, 5= 15458, 6= 9137, 7= 6548, 8= 21957, 9= 36529, 10= 18685, 11= 16965, 12= 20124, 13= 14731, 14= 24923, AND 15= 17834. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439680 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR