BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1800753 · Received August 12, 2010

    Report

    Report Number
    3006630150-2010-01378
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    June 11, 2010
    Report Date
    July 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THE LEAD WAS DISCARDED AND THE IPG WAS KEPT BY THE PT. A REVIEW OF THE MFG DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MFG. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS EXPLANTED DUE TO INFECTION. THE INFECTION STARTED AT THE LEAD INCISION SITE AND SPREAD TO THE IPG SITE. THE PT WAS GIVEN IV ANTIBIOTICS AND IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8120-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IPG KIT (WITHOUT PULL - THROUGH TUNNELER)| MODEL # SC-1110-02| SERIAL # (B)(4)