BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8454138 · Received March 26, 2019

    Report

    Report Number
    3006630150-2019-01341
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    March 13, 2019
    Report Date
    March 26, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER:5101145/5100139; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. MODEL NUMBER/CATALOG NUMBER: SC-2218-70; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5088479; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE OF THE COMPLAINT DEVICE 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 DEVELOPED A STAPHYLOCCOCUS INFECTION AT THE IPG AND LEAD SITE. IT WAS ALSO REPORTED THAT THE PHYSICIAN SUSPECTED THE PATIENT WAS RUBBING THE INCISION WHICH CAUSED INFECTION. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245746 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 346269 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention