BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2153357 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-00898
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 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
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE INFORMATION WAS PROVIDED FOR THE EXPLANTED LEADS; THEREFORE, THE MODEL AND LOT NUMBERS AS WELL AS THE IMPLANT, MANUFACTURING AND EXPIRATION DATES ARE UNKNOWN. RESULTS: AS RECEIVED, THE RETURNED LEADS WERE CUT AND INCOMPLETE. THEREFORE NO FUNCTIONAL TESTING COULD BE PERFORMED. THE CUT ENDS OF THE RETURNED INCOMPLETE LEADS WERE CONSISTENT WITH EXPLANT DAMAGE; NO OTHER ANOMALIES WERE OBSERVED. 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 2 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00897 THE PATIENT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND TWO LEADS. IT WAS REPORTED THAT THE PATIENT COULD FEEL NO STIMULATION EVEN AT MAXIMUM AMPLITUDE. IN ADDITION, SHE ALLEGED THAT THE RECHARGE BURDEN FOR HER IPG HAD SUDDENLY INCREASED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPLACE THE PATIENT'S IPG AND LEADS AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention