BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9631500 · Received January 27, 2020

    Report

    Report Number
    3006630150-2020-00189
    Event Type
    Injury
    Date Received
    January 27, 2020
    Date of Event
    January 6, 2020
    Report Date
    February 21, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. MODEL NUMBER/CATALOG NUMBER: SC-2317-70 SERIAL NUMBER: (B)(4) BATCH/LOT NUMBER: 5163214/5164342 MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOMS WERE REDNESS AND FLUID DISCHARGES COMING OUT FROM THE POCKET SITE. IT WAS ALSO STATED THAT THE PATIENTS WOUND WAS OPEN AND WAS EXPERIENCING MALAISE. IT WAS UNKNOWN WHAT CAUSED THE INFECTION BUT IT WAS NOT PROCEDURE RELATED. THE PATIENT WAS HOSPITALIZED AND PLACED ON INTRAVENOUS ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOMS WERE REDNESS AND FLUID DISCHARGES COMING OUT FROM THE POCKET SITE. IT WAS ALSO STATED THAT THE PATIENTS WOUND WAS OPEN AND WAS EXPERIENCING MALAISE. IT WAS UNKNOWN WHAT CAUSED THE INFECTION BUT IT WAS NOT PROCEDURE RELATED. THE PATIENT WAS HOSPITALIZED AND PLACED ON INTRAVENOUS ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95539 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 358413 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention