BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET PICOTIP

    MDR report key: 1980986 · Received February 8, 2011

    Report

    Report Number
    2124215-2011-02181
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS RA LEAD REMAINS ACTIVELY IN SERVICE, ALONG WITH THE REST OF THE DEVICE SYSTEM. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD DID EXHIBIT A GRADUAL INCREASE IN IMPEDANCE MEASUREMENT, MOST RECENTLY GREATER THAN 2,000 OHMS. THIS LEAD HAD BEEN IMPLANTED MORE THAN NINE YEARS PRIOR. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION. THERE WERE NO ALLEGATIONS AGAINST THE ASSOCIATED MEDICAL DEVICE. ALL OTHER LEAD MEASUREMENTS WERE NOTED WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4053

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR 4035| 4053| 1280