BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3890859 · Received June 4, 2014

    Report

    Report Number
    1627487-2014-03377
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 RELATED TO THIS EVENT WERE FOUND. CONCLUSION - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 4. REFERENCE MFR. REPORTS: 1627487-2014-03378, 1627487-2014-03379 AND 1627487-2014-03390. THE PATIENT HAS 2 SCS ANCHORS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT EXPERIENCED A HEADACHE ACCOMPANIED BY A STIFFENED NECK. AS A RESULT, THE PATIENT WAS SENT TO THE E.R. WHERE A CT LUMBAR SCAN WAS DONE BUT NO ANOMALIES WERE FOUND. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED AN ELEVATED WHITE BLOOD CELL COUNT AND ERYTHEMA AT HIS LUMBAR INCISION (PHYSICIAN OBSERVED). ADDITIONALLY, IT WAS REPORTED THE LEAD SITE WAS OPENED AND REVEALED A SUPERFICIAL HEMATOMA WITH FLUID. THE PHYSICIAN THEN RELEASED PRESSURE FROM THE HEMATOMA WHICH IMPROVED THE SITE. MOREOVER, IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND RECEIVED INTRA-VENOUS ANTIBIOTICS. FURTHER INVESTIGATION IDENTIFIED THE PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO A STAPH INFECTION (GRAM STAIN CONFIRMED) AT BOTH THE SCS LEAD INCISION AND SCS IPG POCKET SITES. ADDITIONALLY, PUS WAS NOTED AT THE SITES. AS OF (B)(6) 2014, THE PATIENT WAS STILL RECEIVING ANTIBIOTICS AND THE WOUND(S) WAS HEALING. IT WAS ALSO REPORTED THE SCS ANCHOR INCISION SITES WERE LEFT OPEN FOR DRAINAGE AT THE TIME OF THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326927 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4432397

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization