BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2052582 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03580
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    December 8, 2010
    Report Date
    April 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 TO Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS 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 DURING A FOLLOW UP VISIT, INTERROGATION REVEALED A MAGNET RATE OF 90 BPM AND GAS GAUGE INDICATING ONE-FOURTH OF BATTERY LIFE REMAINING. THREE MONTHS EARLIER THE MAGNET RATE WAS 100 BPM. THERE WAS CONCERN REGARDING THE MAGNET RATE DECREASE AND THE DISCREPANCY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 THAT THIS DEVICE WAS EMERGENTLY EXPLANTED WHILE THE PATIENT WAS OUT OF THE COUNTRY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS NOT INCLUDED IN AN ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1294

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention