BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA®

    MDR report key: 6201407 · Received December 22, 2016

    Report

    Report Number
    3006630150-2016-03866
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 13, 2016
    Report Date
    December 13, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE IPG WAS NOT CHARGING. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE IPG WAS NOT CHARGING. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848005 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR