BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCOLADE MRI

    MDR report key: 12365037 · Received August 24, 2021

    Report

    Report Number
    MW5103468
    Event Type
    Death
    Date Received
    August 24, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 23, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY HUSBAND WAS SUFFERING FROM POST-HERPETIC NEURALGIA FOLLOWING A CASE OF SHINGLES. WE VISITED THE ER AT (B)(6) MEDICAL ON (B)(6) 2021 AND ALL THEY DID EACH TIME WAS CHANGE MEDICATION. WAS IN VERY SEVERE PAIN, MOSTLY AROUND THE AREA WHERE HIS PACEMAKER WAS. ON (B)(6) 2021 HE BEGAN HAVING SEIZURES AND WAS ADMITTED TO (B)(6) MED FOR TESTING. HAD CARDIAC CATH, ABLATION, AND HIS PACEMAKER WAS CHECKED. EVERYTHING CAME BACK NORMAL. DIAGNOSED WITH AFIB. HE CONTINUED TO HAVE WHAT HE CALLED ELECTRIC SHOCKS ACROSS THE AREA OF HIS PACEMAKER CONTINUOUSLY THROUGHOUT EVERY DAY, BUT CHECK ON PACEMAKER BY CARDIOLOGIST CAME BACK FINE. BUT HE INSISTED THIS PAIN WAS BEING CAUSED BY THE PACEMAKER. ON (B)(6) 2021 AFTER EATING BREAKFAST HE WENT TO BEDROOM TO GET DRESSED. I HEARD A HORRIBLE CRASH AND RAN INTO THE BEDROOM TO DISCOVER HIM FLAT ON HIS BACK, UNCONSCIOUS AND MAKING A TERRIBLE RASPING SOUND. I CALLED 911 AND THEY ARRIVED WITH MINUTES, INTUBATED HIM AND EMS TRANSPORTED HIM TO (B)(6) TRAUMA CENTER IN (B)(6). ON (B)(6) 2021 11:00 PM THE HOSPITAL CALLED AND TOLD ME TO GET BACK THERE. WE TOOK HIM OFF LIFE SUPPORT AT SHORTLY AFTER 2:15 A.M. AND HE PASSED AWAY WITHIN 10 MINUTES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260434 ACCOLADE MRI IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L311

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| L| O