BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NEUROMODULATION

    MDR report key: 7095210 · Received December 1, 2017

    Report

    Report Number
    7095210
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 21, 2017
    Report Date
    November 29, 2017
    Manufacturer
    MEDTRONIC
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD SURGICAL PROCEDURE TO TEST SUSPECTED NONFUNCTIONING LEAD OF IMPLANTABLE PULSE GENERATOR, INITIALLY INSERTED ON (B)(6) 2016. UPON TESTING, THE IMPEDANCES OF THE LEFT LEAD WERE FOUND TO BE OUT OF WITHIN NORMAL LIMITS, AND IT WAS DETERMINED THE LEAD NEEDED TO BE REPLACED. AFTER SPEAKING WITH THE PHYSICIAN, HE STATES THE LEAD SHOWED NO EVIDENCE OF DAMAGE, FRACTURE OR MIGRATION, AND THE BATTERY WAS FUNCTIONING APPROPRIATELY. HE ADDED HE HAS NEVER HAD A LEAD SIMPLY NOT WORK LESS THAN A YEAR AFTER INSERTION. LOT NUMBER: BECAUSE LEAD WAS PLACED LAST YEAR AND ORIGINAL PACKAGING IS NO LONGER AVAILABLE, WILL INCLUDE BOTH LOT NUMBERS OF THE TWO LEADS NOTED IN THE OPERATIVE REPORT FROM THE INSERTION ON (B)(6) 2016: LOT #VA18XRZ021 AND #VA18XRZ022. (THE LOT NUMBERS WERE NOT SPECIFIED WITH WHICH LEAD THEY CORRELATE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853796 MEDTRONIC NEUROMODULATION LEAD 60M COMPACT VECTRIS LOG435626 LGW MEDTRONIC 977A260 (SEE B.5)

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization