BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2911730 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16211
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. AS THERE WILL BE RETURN OF PRODUCT, BOSTON SCIENTIFIC CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN INTENDED DEVICE REPLACEMENT PROCEDURE (INSIGNIA 1190 SN (B)(4)), UPON OPENING THE PACEMAKER POCKET, THE PATIENT BECAME ASYSTOLIC WITH NO PACING FROM THE DEVICE FOR APPROXIMATELY THIRTY SECONDS. EXTERNAL TRANSCUTANEOUS PACING WAS DELIVERED AND AN INTRINSIC ESCAPE RHYTHM OF 25 BEATS PER MINUTE FOLLOWED. WHEN THE DEVICE WAS REMOVED FROM THE POCKET, VISUAL INSPECTION REVEALED THIS LEAD WAS SHARPLY BENT AND POSSIBLY FRACTURED. IT WAS THOUGHT THIS WAS DUE TO THE LEAD POSITION BEHIND THE DEVICE IN THE POCKET FROM A PREVIOUS DEVICE REPLACEMENT PROCEDURE. IN ADDITION, IMPEDANCE MEASUREMENTS WERE CHRONICALLY HIGH BUT WERE NOT OUT OF ACCEPTABLE LABELING RANGE. RECENT MEASUREMENTS REVEALED THE IMPEDANCE HAD DECREASED TO A LOW OUT OF RANGE MEASUREMENT. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. THE DEVICE WAS ALSO REPLACED AND WHEN RECONNECTED TO THE REPLACEMENT LEAD, ACCEPTABLE MEASUREMENTS WERE OBTAINED. THE PATIENT WAS MONITORED IN THE CORONARY CARE UNIT AND DISCHARGED THE FOLLOWING DAY WITHOUT ANY FURTHER ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18464 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4035

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 1190| 1174| 4035