BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3414418 · Received October 16, 2013

    Report

    Report Number
    3004209178-2013-19217
    Event Type
    Injury
    Date Received
    October 16, 2013
    Date of Event
    December 11, 2012
    Report Date
    September 27, 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 3998, LOT# LA2153, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: LEAD: PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 74002, LOT# N226309, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAS EXPERIENCED SHOCKING AT THE INS POCKET SITE WHEN HE SITS IN A CERTAIN POSITION SINCE THE INS WAS IMPLANTED. THE PROBLEM WAS REPEATABLE. HE DOES GET GOOD COVERAGE. IMPEDANCE TEST WAS RAN AND ELECTRODE 5-7 COMBINATION WAS LOW OF 67 OHMS. REPROGRAMMING WAS ATTEMPTED TO CORRECT THE PROBLEM BUT IT DID NOT RESOLVE THE ISSUE, HE STILL FELT SHOCKING IN CERTAIN POSITION. LOW IMPEDANCES SHOWED WHEN THE IMPEDANCES WERE TESTED WHEN HE WAS ON HIS BACK. THE PATIENT HAS MENTIONED THIS PROBLEM TO HIS DOCTOR BEFORE AND REPROGRAMMING WAS TRIED. IMPEDANCE TESTS: WHEN SITTING: 1 725 588 2 849 588 3 869 608 4 981 725 5 860 67 (7) 6 918 692 7 67 (5) 873 WHEN LYING: 983 625 582 720 582 843 872 603 983 720 68 856 917 679 68 868. THE COMPANY REPRESENTATIVE CONFIRMED THAT NO DIAGNOSTICS WERE PERFORMED. ELECTRODES 5 AND 7 SHOWED A SHORT CIRCUIT. THE PATIENT WAS BEING SCHEDULED IN NOVEMBER FOR A REVISION OF A POCKET ADAPTOR AND/OR POSSIBLE REVISION LEAD IF NEEDED. THE PATIENT WAS DOING OKAY BUT WAS STILL GETTING SHOCKING AT THE BATTERY SITE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A NEW POCKET ADAPTOR PUT IN AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530740 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention