BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9341799 · Received November 19, 2019

    Report

    Report Number
    3006630150-2019-06634
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 27, 2019
    Report Date
    December 6, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7060897, MODEL/CATALOG DESCRIPTION: COVERAGE 32 SURGICAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE PRODUCTS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING THE MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICE WERE FOUND TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION STARTED AT THE IPG SITE AND THEN PROGRESSED TO THE LEAD A INCISION SITE. SYMPTOMS WERE REDNESS AND SWELLING AROUND BOTH INCISION SITES, WHICH LEAD TO THE PATIENT HAVING A HIGH FEVER. PHYSICIAN DOES NOT BELIEVE IT IS DEVICE RELATED. THE PATIENT HAD OTHER MEDICAL ISSUE AND HAD A WEAKENED IMMUNE SYSTEM WHICH MAY HAVE CONTRIBUTED TO THE INFECTION. THE PATIENT WAS ADMINISTERED WITH INTRAVENOUS ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135498 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 359577 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention