BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10371568 · Received August 6, 2020

    Report

    Report Number
    3006630150-2020-03268
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 6, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7072494/ 7075859.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION ON THE POCKET SITE. SYMPTOMS OF INCREASED PAIN, DRAINAGE AND REDNESS WERE NOTED. IT WAS UNKNOWN IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. HOWEVER, THE PHYSICIAN DID REQUEST WHAT METAL ALLOYS WAS THE IPG MADE OF. IT WAS ALSO NOTED THAT THE PATIENT HAD AN INFECTION BEFORE AND WAS EXPLANTED (RFB 3006630150-2019-07275). THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN EVERYTHING WAS REMOVED AND WERE DISCARDED. THE PATIENT WAS PLACED BACK ON ANTIBIOTICS AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837147 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 367901 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention