BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8634481 · Received May 22, 2019

    Report

    Report Number
    3006630150-2019-02407
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 21, 2019
    Report Date
    June 12, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT REDNESS, SWELLING, AND TENDERNESS WERE RELATED TO ADAPTERS AND WERE PRESENT IN THE NEW BATTERY SITE. THE PATIENT WAS GIVEN FLUIDS AND WAS PLACED ON MULTIPLE ANTIBIOTICS. IT WAS ALSO REPORTED THAT THE PATIENT WAS IN THE INTESIVE CARE UNIT (ICU). THE PATIENT WAS PRESCRIBED MEDICATION UPON DISCHARGED. THE PATIENT WAS EXPERIENCING LEG MUSCLE PAIN AND WEAKNESS POSTOPERATIVELY.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT FOLLOWING A POST-OPERATIVE PROCEDURE THE PATIENT EXPERIENCED SEPTIC SHOCK THAT DEVELOPED INFECTION. IT WAS BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-9218-15, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7033454/7033456/7033855/7034192, MODEL/CATALOG DESCRIPTION: PRECISION M8 ADAPTER 15CM. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION THEREFORE A FAILURE 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 FOLLOWING A POST-OPERATIVE PROCEDURE THE PATIENT EXPERIENCED SEPTIC SHOCK THAT DEVELOPED INFECTION. IT WAS BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425173 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 348289 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R