BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2240221 · Received September 9, 2011

    Report

    Report Number
    3006630150-2011-01378
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    September 21, 2010
    Report Date
    August 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE THE PHYSICIAN WAS NO LONGER AT THE OFFICE. THE OFFICE'S PHYSICIAN INFORMED THE BSN REPRESENTATIVE THAT THE PATIENT DID NOT HAVE A DEVICE RELATED INFECTION BUT COULD NOT CONFIRMED IT. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE HAS HAD SEVERAL INFECTIONS SINCE BEING IMPLANTED AND IS REQUESTING TO BE EXPLANTED. THE PATIENTS SYMPTOM INCLUDED REDNESS AND SHE WAS PRESCRIBED ANTIBIOTICS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE HAS HAD SEVERAL INFECTIONS SINCE BEING IMPLANTED AND IS REQUESTING TO BE EXPLANTED. THE PATIENTS SYMPTOM INCLUDED REDNESS AND SHE WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention