BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10509798 · Received September 9, 2020

    Report

    Report Number
    3006630150-2020-04067
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: LINEAR LEAD KIT 50 CM, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7072207 / 7074089.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOMS OF PAIN FEVER AND OOZING AT THE IPG SITE. THE PATIENT WAS PLACED WITH ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE, EXPECTED TO FULLY RECOVER. THE PHYSICIAN STATED THAT THE INFECTION WAS A RESULT OF A RECENT IMPLANT. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974132 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 365043 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention