BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION SPECTRA

    MDR report key: 13716578 · Received March 9, 2022

    Report

    Report Number
    3006630150-2022-00938
    Event Type
    Death
    Date Received
    March 9, 2022
    Date of Event
    April 1, 2019
    Report Date
    March 9, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT SOURCE: FAMILY MEMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENTS FAMILY MEMBER THAT THE SPINAL CORD STIMULATION PATIENT WAS HOSPITALIZED THREE TIMES WITH THE LAST VISIT HAVING BEEN AROUND EARLY (B)(6) 2019. DURING THIS LAST VISIT TO THE HOSPITAL, THE PATIENT WAS DIAGNOSED WITH AN ACUTE ISSUE AND WAS NOT EXPECTED TO LIVE BUT WAS ADMITTED TO THE ICU AND TREATED FOR LEUKEMIA. THIS TREATMENT PROVED TO BE POSITIVE, HOWEVER, THE PATIENT EXPERIENCED AN INFECTION. THE FAMILY MEMBER STATED THAT THE PHYSICIANS DECIDED THE SOURCE OF THE INFECTION WAS CAUSED BY THE SPINAL CORD STIMULATOR SCS IMPLANT AND SUGGESTED REMOVAL. FURTHER EXPLANATION FROM ANOTHER PHYSICIAN TO THE FAMILY MEMBER STATED THAT IF THE SPINAL IMPLANT WERE TO BE REMOVED, THE PATIENT WOULD BLEED OUT AND WOULD NOT SURVIVE THE SURGERY. THE PATIENT PASSED AWAY. THE FAMILY MEMBER BELIEVES THAT THE DEVICE HASTENED THE PATIENTS PHYSICAL DECLINE AND SUBSEQUENT DEATH, IN ADDITION, IT WAS BELIEVED THAT THE DEVICE SHOULD NEVER HAVE BEEN IMPLANTED AND THAT THE GENERAL POOR HEALTH AND BONE QUALITY WAS NOT ASSESSED SUFFICIENTLY PRIOR TO THE FIRST SURGERY. NO FURTHER INFORMATION REGARDING THE DEVICE OR EVENT CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361787 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death