BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8087044 · Received November 19, 2018

    Report

    Report Number
    3006630150-2018-61820
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    September 19, 2018
    Report Date
    May 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE LEAD SITE. THE PATIENT WAS PRESCRIBED WITH PATCHES. MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7023840, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD BURNING SENSATION AND PAIN AT THE IPG SITE. IT WAS REPORTED THAT IT HAPPENS WHEN STIMULATION IS ON. PATIENT HAD A FEVER BUT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE PATIENT WAS PRESCRIBED WITH LIDOCAINE PATCHES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD BURNING SENSATION AND PAIN AT THE IPG SITE. IT WAS REPORTED THAT IT HAPPENS WHEN STIMULATION IS ON. PATIENT HAD A FEVER BUT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE PATIENT WAS PRESCRIBED WITH LIDOCAINE PATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923493 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 339692 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention