BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9302621 · Received November 10, 2019

    Report

    Report Number
    3006630150-2019-06378
    Event Type
    Injury
    Date Received
    November 10, 2019
    Date of Event
    October 21, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG INCISION SITE. SYMPTOMS OF ERYTHEMA AND MILKY YELLOW DRAINAGE WERE NOTED. IT WAS ALSO MENTIONED THAT THE PATIENT WAS FEELING UNWELL, HAD DECREASED IN ENERGY, AND FEVERISH. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT PROCEDURE RELATED, BUT THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-70; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5124024; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. MODEL NUMBER/CATALOG NUMBER: SC-2317-70; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5156896; MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT 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 HAD AN INFECTION AT THE IPG INCISION SITE. SYMPTOMS OF ERYTHEMA AND MILKY YELLOW DRAINAGE WERE NOTED. IT WAS ALSO MENTIONED THAT THE PATIENT WAS FEELING UNWELL, HAD DECREASED IN ENERGY, AND FEVERISH. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT PROCEDURE RELATED, BUT THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097137 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 354619 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention