BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2871446 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-13158
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    REFERENCE MFR. REPORT: 1627487-2012-13157. IT WAS REPORTED THE PATIENT HAD DISCOMFORT AT HIS IPG SITE. SURGICAL INTERVENTION RELOCATED THE PATIENT'S IPG AND RESOLVED THE ISSUE. IT WAS ALSO REPORTED DURING THIS SURGICAL PROCEDURE, THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED ALLEGEDLY DUE TO BODY FLUIDS BEING INSIDE THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3246147

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention