BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA LEAD

    MDR report key: 2133425 · Received June 15, 2011

    Report

    Report Number
    1627487-2011-02820
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT REC'D HER SCS SYS ON AN UNK DATE. IT WAS REPORTED THAT THE LEAD CONTACTS WERE READING AS INVALID. IT WAS FOUND THAT THE LEAD HAD MIGRATED. THE SCS SYS WAS REPLACED ON (B)(6) 2011 AND THE PT HAD GOOD STIMULATION POST-OPERATIVE. THE EXPLANTED LEAD WAS DISCARDED. NO ADD'L INFO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3716