BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, 30CM

    MDR report key: 2153348 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-00895
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    December 17, 2010
    Report Date
    June 3, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    THE PATIENT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING A LEAD EXTENSION ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL AND SINCE THE INCIDENT LOST STIMULATION. A DIAGNOSTIC TEST REVEALED LOW IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2010 TO ADDRESS THIS ISSUE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE LEAD EXTENSION WAS BENT AND WHEN TESTED INTRAOPERATIVELY IN CONJUNCTION WITH THE PATIENT'S LEAD, IMPEDANCE ISSUES WERE NOTED. AS SUCH, THE LEAD EXTENSION WAS REPLACED. THE PATIENT'S LEAD WAS ALSO REPOSITIONED, AND EFFECTIVE THERAPY WAS CAPTURED AS A RESULT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE EXPLANTED EXTENSION WAS DISCARDED BY THE MEDICAL FACILITY. (REFERENCE MFR. REPORT # 1627487-2010-03176 FOR RELATED REPORTS.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, 30CM SPINAL CORD STIMULATION LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3100679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL 3788| SCS LEADS (2): MODEL UNK| IMPLANTED:| IMPLANTED: