BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1980322 · Received February 2, 2011

    Report

    Report Number
    3006630150-2011-00173
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A LEAD REVISION. THE PHYSICIAN REPLACED THE LEAD WITH A NEW LEAD. THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED LEAD REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS NOT RECEIVING ANY STIMULATION. ALL CONTACTS ON THE LEAD ARE SHOWING HIGH IMPEDANCE READING. AN X RAY TAKEN DIDN'T SHOW ANY LEAD MIGRATION. THE PHYSICIAN WOULD LIKE TO REVISE THE PATIENT'S LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS NOT RECEIVING ANY STIMULATION. ALL CONTACTS ON THE LEAD ARE SHOWING HIGH IMPEDANCE READING. AN X RAY TAKEN DIDN'T SHOW ANY LEAD MIGRATION. THE PHYSICIAN WOULD LIKE TO REVISE THE PATIENT'S LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2138-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention