BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4815198 · Received June 3, 2015

    Report

    Report Number
    3004209178-2015-10188
    Event Type
    Injury
    Date Received
    June 3, 2015
    Report Date
    May 18, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7 4001, LOT# N466463, IMPLANTED: 2014 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 3487A-33, LOT# V072248, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS NORMAL BATTERY DEPLETION AND A REPLACEMENT SURGERY WAS ANTICIPATED ONCE THERE WAS INSURANCE APPROVAL, BUT HAS NOT YET BEEN SCHEDULED. THE STIMULATION WAS NOT WORKING AND UPON INTERROGATION, AN END-OF-SERVICE (EOS) MESSAGE ON THE PROGRAMMER WAS OBSERVED AND IT WAS LATER DETERMINED THAT THERE WAS PREMATURE BATTERY DEPLETION, NOT NORMAL DEPLETION. IMPEDANCE TESTING WAS PERFORMED AND EVERYTHING WAS NORMAL. THE PREVIOUS BATTERY LASTED 2 YEARS AND THE MANUFACTURER REPRESENTATIVE (REP) LOOKED AT THE SETTINGS AND HIS RATE WAS AT 115 HERTZ. THE PATIENT WAS EXPERIENCING A LOSS OF EFFECT AND A RETURN OF HIS NORMAL PAIN IN THE BACK AND LEGS. THE REP DISCUSSED WITH THE PATIENT THAT THE RATE OF USE WAS A DRIVER FOR BATTERY DEPLETION AND THE PATIENT SAID THAT RATE WAS ALL THAT WORKED FOR HIS PAIN. A RECHARGEABLE BATTERY WAS DISCUSSED FOR A REPLACEMENT. IF ADDITIONAL INFORMATION REGARDING THE PATIENT¿S OUTCOME OR WHEN A REPLACEMENT WILL BE SCHEDULED BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359118 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention