BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11633659 · Received April 8, 2021

    Report

    Report Number
    3006630150-2021-01459
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 8, 2021
    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 · 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: 7081442/7084492.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT POCKET INCISION SITE. SYMPTOMS OF PUS, REDNESS, AND OPENED INCISION WERE NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED BUT DUE PATIENT BEING DIABETIC WHICH CONTRIBUTED THE INFECTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531602 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 373220 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention