BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2051649 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03324
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE AND LEADS REMAIN IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR LEAD HAD PREVIOUSLY DISPLAYED A LEAD SAFETY SWITCH. IT WAS THOUGHT THIS WAS DUE TO A LEAD FRACTURE. INCREASED THRESHOLD AND PACING INHIBITION HAD BEEN OBSERVED. PREVIOUSLY, THE DEVICE HAD BEEN PROGRAMMED TO UNIPOLAR PACING AND SENSING. A REVISION PROCEDURE WAS PERFORMED. WHEN THE PACEMAKER WAS REMOVED FROM THE POCKET, A VISUAL INSPECTION REVEALED THE DISTAL SETSCREWS WERE TIGHT; HOWEVER THE PROXIMAL SETSCREWS WERE NOT TIGHT. SENSING FUNCTIONS OF THE LEADS WERE WITHIN ACCEPTABLE RANGES. PREVIOUSLY, RIGHT VENTRICULAR LEAD IMPEDANCE MEASUREMENTS WERE LOW, HOWEVER WITHIN ACCEPTABLE RANGE. BOTH THE ATRIAL LEAD AND RIGHT VENTRICULAR LEAD WERE DISCONNECTED AND RESEATED SECURELY. NO ISSUES WERE REVEALED WITH SENSING; NORMAL IMPEDANCE AND THRESHOLD MEASUREMENTS WERE OBTAINED. THE FOLLOWING DAY, INTERROGATION REVEALED ONE HIGH OUT OF RANGE IMPEDANCE MEASUREMENT WITH A CORRESPONDING LOSS OF CAPTURE AT 6.5 V HAD OCCURRED. ISOMETRICS DID NOT REVEAL ANY FURTHER ISSUES. THE OUT OF RANGE MEASUREMENTS COULD NOT BE REPRODUCED. STABLE IMPEDANCE AND THRESHOLD MEASUREMENTS WERE OBTAINED. THE DEVICE AND LEADS REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WITH THIS DEVICE AND LEAD HAS AN INTRINSIC SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R 4480| 4087| 4457| 1297