BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2212202 · Received August 15, 2011

    Report

    Report Number
    3006630150-2011-01279
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION APPEARS TO HAVE DISSIPATED. NO FURTHER ACTION WILL BE TAKEN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS REDNESS AND OOZING AT THE POCKET SITE. THE PHYSICIAN PUT THE PATIENT ON ORAL ANTIBIOTICS. THE PATIENT HAS HAD PREVIOUS INFECTIONS WHICH ARE NOT DEVICE RELATED. THE PATIENT SHOWERED BEFORE SHE WAS ADVISED TO SHOWER, THUS THE POTENTIAL FOR INFECTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS REDNESS AND OOZING AT THE POCKET SITE. THE PHYSICIAN PUT THE PATIENT ON ORAL ANTIBIOTICS. THE PATIENT HAS HAD PREVIOUS INFECTIONS WHICH ARE NOT DEVICE RELATED. THE PATIENT SHOWERED BEFORE SHE WAS ADVISED TO SHOWER, THUS THE POTENTIAL FOR INFECTION.

    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 49 YR Required Intervention