BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, 30 CM

    MDR report key: 2210497 · Received August 10, 2011

    Report

    Report Number
    1627487-2011-06049
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K991784
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: VISUAL EXAMINATION OF THE LEAD EXTENSION REVEALED THAT ALL OF THE WIRES FROM THE HEADER WERE PULLED BACK AND EXTRACTED TO THE STRAIN RELIEF. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE BROKEN WIRES. MOST LIKELY THE STRESS WAS INDUCED WHILE THE DEVICE WAS IMPLANTED. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2011-06048. THE PT'S (B)(6) SCS SYSTEM INCLUDED AN IPG, LEAD AND LEAD EXTENSION. IT WAS REPORTED THAT THE PT WAS WITHOUT STIMULATION. BEFORE THE STIMULATION CEASED, THE PT'S THERAPY WAS ALLEGEDLY INTERMITTENT, AND THE IPG HAD BECOME DIFFICULT TO RECHARGE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO ADDRESS THIS MATTER. PRIOR TO THE PROCEDURE, THE PT'S IPG REGISTERED A LOW BATTERY WARNING. ATTEMPTS TO RECHARGE THE DEVICE WERE REPORTEDLY UNSUCCESSFUL. INTRAOPERATIVE TESTING OF THE PT'S LEAD REVEALED NORMAL IMPEDANCE READINGS WHEN TESTED INDEPENDENTLY. HOWEVER, WHEN THE LEAD WAS TESTED IN CONJUNCTION WITH THE LEAD EXTENSION, HIGH IMPEDANCE MEASUREMENTS WERE OBSERVED. FURTHER INTERROGATION REVEALED THAT THE PT'S EXTENSION WAS BROKEN. AS SUCH, BOTH THE PT'S IPG AND LEAD EXTENSION WERE REPLACED. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, 30 CM SPINAL CORD STIMULATION LEAD EXTENSION GZB ST. JUDE MEDICAL - NEUROMODULATION 3383 84794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS LEAD: MODEL UNK| IMPLANTED: