BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA LEAD

    MDR report key: 2220259 · Received August 16, 2011

    Report

    Report Number
    1627487-2011-08058
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: AS RECEIVED, THE LEADS WERE CUT AND THE CUTS WERE CONSISTENT WITH EXPLANT PROCEDURE. SINCE THE LEADS WERE CUT, NO ELECTRICAL TESTING COULD BE PERFORMED. VISUAL INSPECTION REVEALED OVERSTRESS INSULATION ON ONE OF THE ELECTRODE ON CHANNEL 5. THIS LIKELY HAPPENED WHEN THE LEADS WERE PULLED. A LOOSE WIRE WAS ALSO OBSERVED WHEN THE INSULATION WAS PULLED. 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 REMOVED SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT RECEIVED INADEQUATE STIMULATIONS DESPITE MULTIPLE PROGRAMMING ATTEMPTS. THE LEAD WAS REMOVED AND THE PHYSICIAN NOTED THAT ONE OF THE LEAD CONTACT WAS DISTORTED. THE PHYSICIAN CUT THE LEAD AND REQUESTED A LEAD EXAMINATION. THE SCS IPG WAS LEFT IN THE POCKET AND THE POCKET WAS NOT OPENED. THE PATIENT MIGHT BE REIMPLANTED AT A FUTURE DATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3131170

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention