BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 2201936 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03842
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAWSUIT ALLEGED THAT THE PATIENT DEVELOPED SEPSIS AND STAPH INFECTIONS AND REMAINED IN THE HOSPITAL FOR A PERIOD OF 10 DAYS TO RECUPERATE FROM SYMPTOMS OF THE INFECTIONS AND SURGERIES. IT WAS FURTHER ALLEGED THAT THE PATIENT SUFFERED SEVERE AND SERIOUS PERSONAL INJURIES, PAIN AND SUFFERING, MENTAL ANGUISH, AND ECONOMIC LOSSES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7299 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R