BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2160378 · Received July 13, 2011

    Report

    Report Number
    3006630150-2011-01027
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE IPG WAS ANALYZED AND PASSED ALL TESTS. IPG EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN REPLACED THE IPG DUE TO PREFERENCE. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED IPG 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 THE PATIENT WOULD UNDERGO AN IPG REVISION. THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING AS THE IPG HAD MIGRATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO AN IPG REVISION. THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING AS THE IPG HAD MIGRATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO AN IPG REVISION. THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING AS THE IPG HAD MIGRATED.

    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 Required Intervention