BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2180318 · Received July 27, 2011

    Report

    Report Number
    3006630150-2011-01171
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS, SPLITTER, AND EXTENSIONS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-2366-50 SERIAL#: (B)(4) DESCRIPTION: LINEAR 3-6 LEAD 50CM; MODEL#:SC-3354-25 SERIAL#: (B)(4) DESCRIPTION: W4 SPLITTER 2X4-25 CM, MODEL# :SC-3138-55, SERIAL#: (B)(4) DESCRIPTION: SCS PHIII EXT 55CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PERMANENT IMPLANT PROCEDURE WAS PROLONGED DUE TO HIGH IMPEDANCE READINGS ON THE LEADS. THE PHYSICIAN WASN'T ABLE TO RESOLVE THE HIGH IMPEDANCE READINGS ON FOUR CONTACTS AND DECIDED TO LEAVE EVERYTHING IMPLANTED AS IS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PERMANENT IMPLANT PROCEDURE WAS PROLONGED DUE TO HIGH IMPEDANCE READINGS ON THE LEADS. THE PHYSICIAN WASN'T ABLE TO RESOLVE THE HIGH IMPEDANCE READINGS ON FOUR CONTACTS AND DECIDED TO LEAVE EVERYTHING IMPLANTED AS IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention