BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITROD 44C SURGICAL LEAD

    MDR report key: 1940595 · Received December 21, 2010

    Report

    Report Number
    1627487-2010-03854
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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

    IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. THE LEAD CONTACTS DEMONSTRATED INVALID IMPEDANCE READINGS. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE LEAD. STIMULATION WAS RECAPTURED AS A RESULT OF THE PROCEDURE. THE EXPLANTED DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITROD 44C SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention