BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9950098 · Received April 10, 2020

    Report

    Report Number
    3006630150-2020-01726
    Event Type
    Injury
    Date Received
    April 10, 2020
    Date of Event
    March 22, 2020
    Report Date
    May 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS DOING WELL AND NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE AND WAS DIAGNOSED WITH "CELLULITIS". SYMPTOMS WERE REDNESS AND PAIN AT THE IPG SITE. THE PHYSICIAN BELIEVED THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. ANTIBIOTICS WERE PRESCRIBED.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-70; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5092162 / 7072180; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE AND WAS DIAGNOSED WITH CELLULITES. SYMPTOMS WERE REDNESS AND PAIN AT THE IPG SITE. THE PHYSICIAN BELIEVED THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. ANTIBIOTICS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414120 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 365682 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention