BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4252891 · Received November 11, 2014

    Report

    Report Number
    1627487-2014-20405
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE SCS IPG REPLACEMENT PROCEDURE (1627487-2014-25636) THE LEAD BROKE IN THE IPG HEADER. THEREFORE, THE PHYSICIAN EXPLANTED THE LEAD AND REPLACED IT WITH ANOTHER ONE WHICH HAS RESOLVED THE ISSUE. THE PROCEDURE WAS EXTENDED FOR 1.5 HRS DUE TO THIS ISSUE. THE PATIENT HAS EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725943 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3523723

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788