BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2018355 · Received March 14, 2011

    Report

    Report Number
    3006630150-2011-00344
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:6060010-002 LOT#:ABC MODEL DESCRIPTION: OR CABLE A RETURNED PRODUCT ANALYSIS INDICATED THAT LEAD SC-2218-50 (B)(4) EXHIBITS NORMAL DEVICE CHARACTERISTICS. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED LEAD SC-2218-50 (B)(4) FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. OR CABLE 1- L: THE COMPLAINT WAS NOT CONFIRMED. THE DEVICES EXHIBIT NORMAL DEVICE CHARACTERISTICS. OR CABLE 2- R: INTERNAL VISUAL INSPECTION CONFIRMED THAT FIVE CONTACTS SPRINGS WERE NOT ALIGNED PROPERLY CREATING PROBLEMS WITH LOCKING MECHANISM. THIS IN TURN CAUSED HIGH IMPEDANCE READINGS FOR THIS OR CABLE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE TRIAL PATIENT WAS EXPERIENCING LOSS OF STIMULATION CAUSED BY ONE OF THE LEADS EXHIBITING HIGH IMPEDENCES. THE PHYSICIAN ATTEMPTED TO RESOLVE THE HIGH IMPEDENCES BUT WAS NOT SUCCESSFUL. THE PHYSICIAN BELIEVED THAT THE LEAD WAS DEFECTIVE. THE PATIENT WAS RECEIVING ADEQUATE THERAPY WITH ONE LEAD. THE PATIENTS TRIAL LEADS WERE PULLED ON TIME AND THE PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE TRIAL PATIENT WAS EXPERIENCING LOSS OF STIMULATION CAUSED BY ONE OF THE LEADS EXHIBITING HIGH IMPEDENCES. THE PHYISICAN ATTEMPTED TO RESOLVE THE HIGH IMPEDENCES BUT WAS NOT SUCCESSFUL. THE PHYISICAN BELIEVED THAT THE LEAD WAS DEFECTIVE. THE PATIENT WAS RECEIVING ADEQUATE THERAPY WITH ONE LEAD. THE PATIENTS TRIAL LEADS WERE PULLED ON TIME AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention