BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2132873 · Received June 17, 2011

    Report

    Report Number
    3006630150-2011-00915
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-2218-70 SERIAL#: (B)(4) DESCRIPTION: ENH ST LD KIT, 70 CM.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE IPG REVEALED A BURN MARK ON THE CASE. DAILY BATTERY DEPLETION RATE WITH STIMULATION TURNED OFF WAS HIGHER THAN SPECIFICATION. SLEEP CURRENT WAS OUT OF THE EXPECTED RANGE AS WELL. IT COULD NOT BE DETERMINED WHICH COMPONENT CAUSED THE HIGH CURRENT DRAIN. THIS APPEARS TO HAVE STARTED FOLLOWING THE PREVIOUS REVISION PROCEDURE. THE IPG PASSED ALL OTHER FUNCTIONAL TESTS PERFORMED. THE EXPLANTED LEADS WERE DAMAGED, BUT THIS TYPE OF DAMAGE IS CONSISTENT TO DAMAGES DONE DURING AN EXPLANT PROCEDURE. A REVIEW OF THE STERILIZATION DOCUMENTATION FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED. THE REASON FOR THE EXPLANT WAS THE PATIENT'S WOUND WOULD NOT HEAL FOLLOWING AN INFECTION FROM A PREVIOUS PROCEDURE (REFER TO MFR. REPORT #3006630150-2010-00402). NO CULTURE WAS TAKEN AND THE PATIENT WAS PRESCRIBED IV ANTIBIOTICS PRIOR TO THE EXPLANT PROCEDURE. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION IS RELATED TO THE DEVICE. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED. THE REASON FOR THE EXPLANT WAS THE PATIENT'S WOUND WOULD NOT HEAL FOLLOWING AN INFECTION FROM A PREVIOUS PROCEDURE (REFER TO MFR. REPORT #3006630150-2010-00402). NO CULTURE WAS TAKEN AND THE PATIENT WAS PRESCRIBED IV ANTIBIOTICS PRIOR TO THE EXPLANT PROCEDURE. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION IS RELATED TO THE DEVICE. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.

    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 33 YR Required Intervention