BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3010007 · Received March 18, 2013

    Report

    Report Number
    3006630150-2013-00463
    Event Type
    Injury
    Date Received
    March 18, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2012.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD BEEN BURNED AT THE POCKET SITE WHILE CHARGING. SYMPTOMS INCLUDE REDNESS AND BLISTERS. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WAS PRESCRIBED WITH TOPICAL OINTMENT. THE PATIENT WAS DOING WELL AND THE BURN IS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111913 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention