BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 60-CM PERCUTANEOUS LEAD

    MDR report key: 2212578 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-04026
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 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

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. DISCOLORATION WAS NOTED ON THE LEAD BODY. FUNCTIONAL TESTING WAS NOT PERFORMED. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE: 1627487-2011-04027. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. DURING A REVISION ON (B)(6) 2011, THE PHYSICIAN FOUND THE LEAD HAD MIGRATED OUT OF THE EPIDURAL SPACE AND WAS TWISTED AROUND THE IPG NUMEROUS TIMES; IN ADDITION, AN INFECTION WAS FOUND AT THE IPG POCKET SITE. THE SYSTEM WAS EXPLANTED ON (B)(6) 2011 AND THE POCKET SITE WAS WASHED WITH ANTIBIOTIC SOLUTION. THE PT WAS GIVEN IV ANTIBIOTIC. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THE PT HAD A SECOND SCS SYSTEM REVISED ON (B)(6) 2011. REFER TO 1627487-2011-04029 REGARDING THIS SECOND SYS SYSTEM REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 60-CM PERCUTANEOUS LEAD SPINAL CORD SOLUTION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3170829

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R IMPLANT:| SCS IPG: MODEL 3788