BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2093762 · Received May 18, 2011

    Report

    Report Number
    3006630150-2011-00705
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WAS MADE TO CONTACT THE PATIENT REGARDING THE IPG REPLACEMENT PROCEDURE WITHOUT SUCCESS. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICE 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 A PATIENT¿S IPG WAS HAVING DIFFICULTIES OBTAINING A FULL CHARGE. THE BSN REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT HOWEVER WAS UNSUCCESSFUL. THE PHYSICIAN HAS RECOMMENDED THE PATIENT TO UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S IPG WAS HAVING DIFFICULTIES OBTAINING A FULL CHARGE. THE BSN REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT HOWEVER WAS UNSUCCESSFUL. THE PHYSICIAN HAS RECOMMENDED THE PATIENT TO UNDERGO AN IPG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR