BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4031493 · Received August 22, 2014

    Report

    Report Number
    3006630150-2014-01900
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    March 11, 2014
    Report Date
    July 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. IT WAS BELIEVED THAT THE IPG WAS TOO SHALLOW AND WAS TILTED IN THE POCKET. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE IPG WAS IMPLANTED DEEPER IN THE POCKET. THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509154 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention