BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 2810877 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06056
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT EXPERIENCED CHRONIC PAIN, WITH SUSPECTED BRACHIAL PLEXOPATHY SECONDARY TO COMPRESSION FROM THE DEVICE. THE POCKET WAS WIDENED AND THE DEVICE WAS RELOCATED TO A MORE MEDIAL DIRECTION. A FEW MONTHS LATER, THE PATIENT EXPERIENCED SHORTNESS OF BREATH, DISCOMFORT, AND PAIN, AND AN LV (LEFT VENTRICULAR) LEAD DISLODGEMENT WAS NOTED. THE LV LEAD WAS TURNED OFF AND LATER EXPLANTED. THE DEVICE REMAINED IN USE, UNTIL BEING EXPLANTED YEARS LATER AT ERI (ELECTIVE REPLACEMENT INDICATOR). NO 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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD