BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2003690 · Received February 23, 2011

    Report

    Report Number
    3006630150-2011-00274
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. THE PATIENT'S IPG AND CERVICAL LEAD REMAIN IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT THAT A PATIENT'S LEAD WAS EXPLANTED DUE TO AN INFECTION WAS RECEIVED. THE INFECTION WAS LOCATED AT THE LUMBAR AND IPG SITE. THE PATIENT'S SYMPTOMS WERE PAIN AT THE LUMBAR AND IPG SITE ALONG WITH HEADACHES. THE PATIENT WAS TREATED WITH VANCOMYCIN AND ZOSYN.

    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 43 YR Hospitalization| R IPG KIT (WITHOUT PULL-THROUGH TUNNELER),| MODEL # SC-2218-70, (B)(4)| MODEL # SC-1110-02, (B)(4)| ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014" STYLET