BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2222081 · Received August 24, 2011

    Report

    Report Number
    3006630150-2011-01324
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-8116-70, SERIAL # (B)(4), DESCRIPTION: ARTISAN 2X8 PADDLE LEAD, 70 CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE PATIENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND PADDLE LEAD 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 WAS EXPERIENCING PAIN AND PINCHING AT THE POCKET SITE, ALONG WITH INADEQUATE STIMULATION DUE TO MULTIPLE NON-DEVICE RELATED FALLS. THE PATIENT WAS EXPLANTED AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention