BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3130887 · Received May 24, 2013

    Report

    Report Number
    3006630150-2013-01033
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE CHARGER WILL NOT BE RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE CHARGER 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 HAD A FIRST DEGREE BURN AT THE POCKET SITE DUE TO CHARGING. THE PATIENT HAD BLISTER OVER THE IMPLANT SITE WHICH NOW TURNED TO A SCAB. THE PATIENT IS DOING WELL FOR NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232126 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-5312 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention