BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION SPECTRA

    MDR report key: 8282570 · Received January 28, 2019

    Report

    Report Number
    3006630150-2019-00253
    Event Type
    Death
    Date Received
    January 28, 2019
    Date of Event
    January 8, 2019
    Report Date
    January 28, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICE: REFERENCE NUMBER (B)(4). PRODUCT FAMILY SCS PADDLE LEADS. UPN (B)(4), MODEL SC 8216 50, SERIAL (B)(4), BATCH (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND PADDLE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. DEVICES NOT RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE PATIENTS WIFE THAT THE PATIENT HAD AN INFECTION AND SUBSEQUENTLY PASSED AWAY DUE TO THE INFECTION. UPON FOLLOW UP WITH THE PHYSICIAN, IT WAS HIS UNDERSTANDING THAT THE PATIENT PASSED AWAY DUE TO UROSEPSIS. IT WAS REPORTED THAT THERE WAS INTERVENTION, HOWEVER THE TYPE OF INTERVENTION IS UNKNOWN. THE PHYSICIAN NOTED THAT THE PASSING WAS NOT DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74725 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 202715 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death