BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 LEAD, 60 CM

    MDR report key: 4760274 · Received May 8, 2015

    Report

    Report Number
    1627487-2015-08265
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 11, 2015
    Report Date
    April 11, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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

    THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) DUE TO AN INEFFECTIVE STIMULATION. REPORTEDLY, THE PATIENT SUFFERED A FALL IN NOVEMBER. THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING ON (B)(6) 2015 TO NO AVAIL. DIAGNOSTIC TESTING REVEALED MULTIPLE CONTACTS WITH INVALID IMPEDANCE. FOLLOW-UP INDICATES THE PATIENT CONSULTED WITH THE PHYSICIAN. AT WHICH TIME, THE PATIENT WAS IMMEDIATELY ADMITTED TO THE HOSPITAL WHERE SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2015. THE LEAD WAS REVISED AND THE IPG REPLACED DURING THE PROCEDURE. EFFECTIVE STIMULATION WAS ACHIEVED POSTOPERATIVELY. REFERENCE MFR REPORT#1627487-2015-15163 REGARDING THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303467 LAMITRODE TRIPOLE 16 LEAD, 60 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 3941568

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization