BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC SENTRY

    MDR report key: 1649175 · Received April 2, 2010

    Report

    Report Number
    2182208-2010-00158
    Event Type
    Death
    Date Received
    April 2, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. REFERENCED ARTICLE: "A RARE TYPE OF VENTRICULAR OVERSENSING IN ICD THERAPY-INAPPROPRIATE ICD SHOCK DELIVERY DUE TO TRIPLE COUNTING." PACE PACING CLIN. ELECTROPHYSIOL. FEBRUARY 1;33(2):E17-E19.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS DEVICE AND THESE LEADS. IT WAS REPORTED THAT VENTRICULAR OVERSENSING OCCURRED FOR A PATIENT WITH WIDE QRS COMPLEXES AND INCREASED POTASSIUM LEVELS. THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO "TRIPLE COUNTING." THE PATIENT WAS BROUGHT TO THE HOSPITAL AND BECAME "RESPIRATORY INSUFFICIENT AND LOST CONSCIOUSNESS." THE AUTHOR INDICATED THAT "DUE TO ELECTRO-MECHANICAL DISSOCIATION AND ECHOCARDIOGRAPHIC FINDINGS, THE RESUSCITATION WAS ABORTED." SUBSEQUENTLY, THE PATIENT EXPIRED. THERE ARE NO DEVICE-RELATED DEATH ALLEGATIONS. FURTHER FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| R