BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140214 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16909
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S DAUGHTER CONTACTED OUR COMPANY TO REPORT THE PATIENT HAD PASSED AWAY AND REQUESTED A DEVICE RETURN KIT FOR THE FUNERAL HOME. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE FUNCTIONALITY CONTRIBUTING TO THE PATIENT'S DEATH; HOWEVER THE CALLER REPORTED SOME SYMPTOMS HER MOTHER HAD WITH THE DEVICE IMPLANT. SHE STATED THE DEVICE WAS SO LARGE THAT IT WAS UNCOMFORTABLE FOR HER TO LIVE WITH. IT STUCK OUT OF HER BODY ABOUT AN INCH AND A HALF AND BECAME A PROBLEM WHEN SHE WOULD ROLL OVER ON HER LEFT OR RIGHT SIDE. THE PATIENT WAS ONLY COMFORTABLE ON HER BACK. THE CALLER ALSO REPORTED THAT WHEN THE PATIENT FIRST GOT THE DEVICE, SHE HAD RECEIVED SEVERAL SHOCKS BECAUSE ONE OF THE LEADS WERE NOT CORRECTLY ATTACHED. ONCE THE PHYSICIAN CORRECTED THIS, WHEN THE DEVICE DID SHOCK HER APPROPRIATELY, IT CAUSED HER TO BRUISE UP. THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619555 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R 4555| 0184| N119| MISMATCH