BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2173960 · Received July 24, 2011

    Report

    Report Number
    3006630150-2011-01092
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-2218-70 SERIAL#: (B)(4) MODEL DESCRIPTION:ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014 INCH STYLET.

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS INDICATED THAT VISUAL INSPECTION OF LEAD (S/N (B)(4))REVEALED THAT THE BODY OF THE DISTAL END HAS BEEN DAMAGED AT ELECTRODES NUMBER 3, 4 AND MISSING TWO ELECTRODES. ELECTRICAL TESTS COULD NOT BE PERFORMED DUE TO FRACTURED CABLES. THE ROOT CAUSE OF THE LEAD DAMAGE IS UNKNOWN. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF LEAD (S/N (B)(4)) FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE TWO CONTACTS WERE DISLODGED FROM THE LEAD AND WERE NOT RECOVERED FROM THE PATIENT. THE PHYSICIAN EXPLANTED THE PATIENT'S SCS SYSTEM AND THE PATIENT WAS REPORTEDLY DOING FINE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE TWO CONTACTS WERE DISLODGED FROM THE LEAD AND WERE NOT RECOVERED FROM THE PATIENT. THE PHYSICIAN EXPLANTED THE PATIENT'S SCS SYSTEM AND THE PATIENT WAS REPORTEDLY DOING FINE.

    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