BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50CM IMPLANT LEAD KIT, SLIM TIP

    MDR report key: 8575372 · Received May 2, 2019

    Report

    Report Number
    1627487-2019-04695
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    March 12, 2019
    Report Date
    June 4, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    UDI-DI
    05415067025531
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INCORRECTLY REPORTED THAT THE EXPLANT OCCURRED ON (B)(6) 2019. THE CORRECT DATE IS (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER SHOULD HAVE BEEN MAY 19, 2019 RATHER THAN MAR 19, 2019.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2019-04696. IT WAS REPORTED THAT THE PATIENT'S LEAD MIGRATED, LEADING TO AN UNINTENDED SENSATION IN THE LEFT FOOT. IN TURN, SURGERY OCCURRED ON (B)(6) 2019 TO EXPLANT AND REPLACE THE LEAD, WHICH ADDRESSED THE ISSUE. IT IS NOT YET KNOWN WHICH OF THE PATIENT'S TWO LEADS WAS EXPLANTED, SO BOTH ARE BEING REPORTED.

    Description of Event or Problem · 1

    REFERENCE MFR REPORT:1627487-2019-04696.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366170 50CM IMPLANT LEAD KIT, SLIM TIP DRG LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN10450-50A AB2189 05415067025531

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other MODEL: MN10450-50A, DRG LEAD