BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2030057 · Received March 25, 2011

    Report

    Report Number
    3006630150-2011-00432
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG PASSED VISUAL, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE POSSIBILITY THAT ELECTRICAL LEAKAGE COULD CAUSE TENDERNESS AND UNCOMFORTABLE SENSATIONS AROUND THE IPG SITE WAS INVESTIGATED. THE IPG OUTPUT WAS MONITORED FOR EXCESSIVE LEAKAGE CURRENT OR SPURIOUS SIGNALS IN A SALINE SOLUTION, WHILE PROGRAMMED TO THE PATIENT'S LATEST SETTING. NO DISCREPANCIES WERE IDENTIFIED. IPG STIMULATION AMPLITUDE AND TIMING WAS MONITORED. NO INTERMITTENT ANOMALIES WERE NOTED IN THE OUTPUT. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS. THEREFORE, THE REPORTED COMPLAINT OF THE IPG CAUSING PAIN AT THE POCKET SITE WAS NOT DUPLICATED OR CONFIRMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS AND LEAD EXTENSIONS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50 SERIAL# (B)(4) DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCHES STYLET MODEL #: SC-3138-35 SERIAL#: (B)(4) DESCRIPTION: LEAD EXTENSION, 35CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A NON DEVICE RELATED FALL, THE PATIENT EXPERIENCED TENDERNESS AND DISCOMFORT AROUND THE IPG SITE. THE PATIENT SUSTAINED BRUISING AROUND THE POCKET SITE DUE TO THE FALL. THE IPG HAD MIGRATED AND WAS TILTED IN THE POCKET SITE. DURING THE PROCEDURE, THE PHYSICIAN CHOSE TO EXPLANT THE ENTIRE SYSTEM AS THE PATIENT WAS ALLERGIC TO NICKEL. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A NON DEVICE RELATED FALL, THE PATIENT EXPERIENCED TENDERNESS AND DISCOMFORT AROUND THE IPG SITE. THE PATIENT SUSTAINED BRUISING AROUND THE POCKET SITE DUE TO THE FALL. THE IPG HAD MIGRATED AND WAS TILTED IN THE POCKET SITE. DURING THE PROCEDURE, THE PHYSICIAN CHOSE TO EXPLANT THE ENTIRE SYSTEM AS THE PATIENT WAS ALLERGIC TO NICKEL. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention