BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4433740 · Received January 20, 2015

    Report

    Report Number
    3004209178-2015-00944
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    December 31, 2014
    Report Date
    January 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT# LB2060, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 74002, LOT# N240233, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HIS DOCTOR OR MANUFACTURING REPRESENTATIVE (REP) AND HIS CONCERNS WERE RESOLVED. THE PATIENT NO LONGER HAD ANY CONCERNS WITH HIS DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT COULD NOT TURN STIMULATION ON. LATER THAT DAY, IT WAS CLARIFIED THAT THE DISPLAY SHOWED END OF SERVICE (EOS). THE PATIENT WAS UNABLE TO ADJUST STIMULATION AS A RESULT. THE STIMULATION WORKED THE DAY PRIOR, BUT STIMULATION WENT OFF AND WHEN THE PATIENT TRIED TO TURN IT BACK ON, THE EOS/¿CALL YOUR DR¿ ICONS WERE DISPLAYED. ADDITIONAL INFORMATION FROM THE PATIENT¿S PHYSICIAN INDICATED THAT THE DEPLETION WAS PREMATURE. A REPLACEMENT WAS PLANNED AND WAS PENDING. THE PATIENT STATUS WAS NOTED TO BE RECOVERED WITHOUT PERMANENT IMPAIRMENT. ADDITIONAL CLARIFICATION ABOUT THE OUTCOME WAS REQUESTED, AS THE PATIENT HAD NOT YET HAD THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46832 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention