BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3953788 · Received July 23, 2014

    Report

    Report Number
    2124215-2014-13788
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    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 A PATIENT REPORTED REDNESS AND SWELLING AT DEVICE SITE AFTER RECEIVING AN APPROPRIATE SHOCK. THE PATIENT WAS GIVEN ANTIBIOTICS BY HIS PHYSICIAN. BOSTON SCIENTIFIC WAS CONTACTED FOR ADDITIONAL GUIDANCE IN REGARDS TO NORMAL REACTIONS POST-SHOCK. THE PATIENT WAS TOLD THAT EACH PATIENT REACTS DIFFERENTLY. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS CONTACTED IN ORDER TO OBTAIN ADDITIONAL INFORMATION. THE REPRESENTATIVE WAS UNAWARE OF THE EVENT AND COULD NOT PROVIDE FURTHER INFORMATION. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431184 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R N119| 0185| 4543| MISMATCH| 0085| H170| H177