BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2040349 · Received February 15, 2011

    Report

    Report Number
    1627487-2011-01237
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATINO DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NONCONFORMANCE RELATED TO THE PRODUCT; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE. PRODUCT WAS REWORKED AND RELEASED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 (B)(6) RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS, ON (B)(6) 2007 FOR LOW BACK AND BILATERAL LEG PAIN. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION TO HER LEFT SIDE. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE, AND LEAD CONTACTS 9-16 REVEALED HIGH IMPEDANCE READINGS. AN X-RAY SHOWED A SLIGHT MIGRATION OF THE LEFT LEAD, BUT NO LEAD FRACTURES WERE OBSERVED. THE PHYSICIAN STATED THAT THE PATIENT HAD PREVIOUSLY HAD A SIMILAR ISSUE WITH THE PATIENT'S LEFT LEAD, AND THE ORIGINAL LEAD WAS ALLEGEDLY EXPLANTED AND REPLACED IN (B)(6) 2009. IT WAS REPORTED THAT A LEAD REPLACEMENT PROCEDURE IS NOT PLANNED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATINO DIVISION 3186 2801980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention