BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3374429 · Received September 27, 2013

    Report

    Report Number
    3004209178-2013-17112
    Event Type
    Malfunction
    Date Received
    September 27, 2013
    Date of Event
    September 9, 2013
    Report Date
    September 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-66, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3887-33, LOT# J0217050V, IMPLANTED: 2003 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7495-66, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3887-33, LOT# J0217050V, IMPLANTED: 2003 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT ON THE DATE OF THIS REPORT. IT WAS CONFIRMED THAT THE DEPLETION OF THE PRIOR INS WAS NORMAL AND THE REASON FOR THE SURGICAL PROCEDURE. THE PATIENT WAS ON 2.1V, 450US, 75HZ, 269 OHMS AND 7.223MA. IT WAS NOTED THAT GROUP IMPEDANCE WAS LOWER THAN USUAL. THE BATTERY LIFE WAS ESTIMATED AT 22 MONTHS. IT WAS NOTED THAT AN ELECTRODE IMPEDANCE TEST WAS CONDUCTED AT 1.5V WITH THE FOLLOWING RESULTS: 0, 3 114; 1,3 631; 2, 3 651; 3,0 114; 4, 3 833, 675-968; 5, 591-879; 6, 690-838; 7, 690-1005. THE REASON FOR THE 113 OHMS VALUE WAS UNKNOWN AND THE PATIENT FELT STIMULATION AS INTENDED. IT WAS FURTHER NOTED THAT THE PATIENT FELT STIMULATION NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490815 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR