BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2221045 · Received August 23, 2011

    Report

    Report Number
    3006630150-2011-01329
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2218-50, (B)(4), DESCRIPTION: LINEAR ST LEAD WITH PRELOADED ENHANCED STYLET - 50 CM, MODEL# SC-1110-02, (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD AND INFECTION AT THE LEAD SITE. THE PATIENT'S SYMPTOM WAS REDNESS AT THE LEAD SITE. THE PHYSICIAN PRESCRIBED A TOPICAL ANTIBIOTIC TO APPLY OVER THE MIDLINE AND POCKET INCISION SITE. THE INCISION SITE HAS SINCE HEALED AND THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention