BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 7980172 · Received October 18, 2018

    Report

    Report Number
    3006630150-2018-61421
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    September 26, 2018
    Report Date
    October 18, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5081028/5081030; MODEL/CATALOG DESCRIPTION:  LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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 THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INFECTION AT IPG AND LEAD SITE. SYMPTOMS OF REDNESS AND DRAINING WAS NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN EVERYTHING WAS REMOVED. THE PHYSICIAN BELIEVE THE INFECTION WAS NOT DEVICE RELATED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822047 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 334477 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R