BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8423351 · Received March 14, 2019

    Report

    Report Number
    3006630150-2019-01076
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    February 19, 2019
    Report Date
    April 15, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENTS INCISION SITE WAS NOT COMPLETELY HEALED. THERE WAS A POCKET OF FLUID AND IT KEEPS BLEEDING. THE PHYSICIAN PUT SILVER NITRATE TO TRY AND STOP THE BLEEDING. IT WAS UNKNOWN IF IT WAS THE POCKET OR THE MIDLINE INCISION THAT WAS NOT HEALED YET.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8216-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7013274, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S INCISION SITE WAS NOT COMPLETELY HEALED. THERE WAS A POCKET OF FLUID AND IT KEEPS BLEEDING. THE PHYSICIAN PUT SILVER NITRATE TO TRY AND STOP THE BLEEDING. IT WAS UNKNOWN IF IT WAS THE POCKET OR THE MIDLINE INCISION THAT WAS NOT HEALED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214332 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 332592 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention