BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2000812 · Received February 17, 2011

    Report

    Report Number
    3006630150-2011-00239
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG AND PADDLE LEAD FOUND THEM TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOMS INCLUDED SWELLING. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION IS DEVICE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOMS INCLUDED SWELLING. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION IS DEVICE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND WAS 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention MODEL# SC-8216-50, SERIAL # (B)(4)| ARTISAN 2X8 PADDLE LEAD (LTM), 50 CM