BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3822026 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09318
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 3888Q45, LOT# VA07N8C, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3888Q45, LOT# VA07N8C, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3888Q45, LOT# VA07LH5, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3888Q45, LOT # VA07LH6, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3888Q45, LOT# VA07N8C, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888Q45, LOT# VA07N8C, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888Q45, LOT# VA07LH5, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888Q45, LOT# VA07LH6, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ETIOLOGY WAS AN EXTERNAL STUDY DEVICE.

    Description of Event or Problem · 1

    IT WAS ALSO NOTED THEY WERE UNABLE TO GET THE PROGRAMMER TO RE-SYNCH WITH THE STIMULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND THERE WAS A CALL YOUR DOCTOR 517 ERROR CODE. IT WAS NOTED THERE WERE SOME SETTINGS IN THE STIMULATOR THAT HAD BEEN KEPT OFF SINCE IMPLANT. THE STIMULATOR WAS INTERROGATED WITHOUT INCIDENT AND THEY SET UP TWO PROGRAMS AND ONE GROUP AND GOT REPORTS. WHILE TESTING THE PATIENT PROGRAMMER THEY HAD THE PATIENT GET IN THREE DIFFERENT POSITIONS. WHILE IN ONE POSITION THE PATIENT WAS TRYING TO PRESS THE OVAL NAVIGATION KEY TO THE RIGHT TO GO TO PROGRAM TWO AND THE PATIENT PRESSED CENTER OF THE OVAL KEY AND GOT THE 517 CODE. IT WAS NOTED ¿18,1¿ ALSO APPEARED ON THE BOTTOM OF THE SCREEN. IT WAS NOTED STIMULATION SHUT OFF AT THAT POINT. THE STIMULATOR WAS RE-INTERROGATED AND NO DATA WAS AVAILABLE AND PROGRAMMING WAS GONE. THEY REPROGRAMMED THE PATIENT AND EVERYTHING WAS FINE. ADDITIONAL INFORMATION REPORTED IT APPEARED THE PATIENT WAS PRESSING THE NAVIGATION KEY TO ACCESS A DIFFERENT PROGRAM WHEN THE 517 CODE APPEARED AND THE LOSS OF THERAPY OCCURRED. ADDITIONAL INFORMATION ALSO NOTED NOT ONLY WERE THE GROUPS CLEARED BUT THE PROGRAMS WERE CLEARED AS WELL. IT WAS REPORTED THERE WAS A 514 ERROR CODE PRESENT. ADDITIONAL INFORMATION REPORTED THE ERROR CODE WAS CLEARED AND REPROGRAMMING WAS DONE. THE EVENT WAS NOTED AS RESOLVED WITHOUT SEQUELAE. THE EVENT WAS NOTED AS NOT RELATED TO IMPLANT PROCEDURE AND NOT APPLICABLE TO DEVICE OR THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTH CARE PROVIDER OF THE CLINICAL STUDY REPORTED, THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS DUE TO THE ERROR CODE. THE ERROR CODE WAS LINKED TO A VERY SPECIFIC SEQUENCE OF EVENTS THAT LEADS TO THE PROGRAMMING BEING CLEARED FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300515 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 DA