BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44 SURGICAL LEAD

    MDR report key: 2091628 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-01458
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    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
    VA, 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

    DEVICE 1 OF 2. REFERENCE MANUFACTURE REPORT: 1627487-2011-01457. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND TWO SURGICAL LEADS, ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT'S CERVICAL LEAD HAD PULLED PARTIALLY OUT OF THE IPG HEADER, WHICH WAS CONFIRMED VIA X-RAY. DIAGNOSTIC TESTS EXHIBITED INVALID IMPEDANCE READINGS ON THE FIVE LEAD CONTACTS AND HIGH IMPEDANCE ON ANOTHER CONTACT. THE PATIENT WAS ALLEGEDLY REPROGRAMMED AROUND THESE LEAD CONTACTS. THE PATIENT STATED DURING REPROGRAMMING THAT SHE FELT A PAINFUL SENSATION AT THE IPG SITE. THE PATIENT WILL CONSULT WITH THE PHYSICIAN ABOUT THE NEXT COURSE OF ACTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3244 69362

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention