BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2212197 · Received August 15, 2011

    Report

    Report Number
    3006630150-2011-01260
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WILL NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    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 PATIENT UNDERWENT A POCKET REVISION PROCEDURE DUE TO DISCOMFORT. DURING REVISION, THE PHYSICIAN EXPLANTED PATIENT'S IPG BECAUSE THE PATIENT NO LONGER WANTED THE IPG. THE LEADS WERE LEFT IMPLANTED IN THE PATIENT. THE PATIENT IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE DUE TO DISCOMFORT. DURING REVISION, THE PHYSICIAN EXPLANTED PATIENT'S IPG BECAUSE THE PATIENT NO LONGER WANTED THE IPG. THE LEADS WERE LEFT IMPLANTED IN THE PATIENT. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention