BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8677172 · Received June 6, 2019

    Report

    Report Number
    3006630150-2019-02661
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 5, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS SYMPTOMS WERE FEVER, CHILLS AND REDNESS AT THE INCISION SITE. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT PROCEDURE RELATED AND THAT THE CAUSE WAS UNKNOWN. THE PHYSICIAN ALSO NOTED THAT THE PATIENT WAS AT HIGH RISK FOR INFECTION. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. MODEL NUMBER/CATALOG NUMBER: SC-8336-50. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: 7034003. MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE BATTERY POCKET SITE. INFECTION WAS SUSPECTED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE PATIENT WAS NOTED OF HAVING MRSA BEFORE AND POSSIBLY DID NOT CLEAR UP BEFORE DEVICE IMPLANTATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE BATTERY POCKET SITE. INFECTION WAS SUSPECTED AS (B)(6). THE PATIENT WAS NOTED OF HAVING MRSA BEFORE AND POSSIBLY DID NOT CLEAR UP BEFORE DEVICE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466645 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 347197 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention