BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 1950303 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22518
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENT HAD BEEN INCREASING FOR SEVERAL MONTHS AND AT THE CURRENT DEVICE INTERROGATION IT MEASURED GREATER THAN 2500 OHMS. THE RV LEAD THRESHOLD MEASUREMENT HAD ALSO RISEN TO 4.5 VOLTS AT 0.5 MS. DURING THE REVISION PROCEDURE, THE RV LEAD WAS SURGICALLY ABANDONED AND THE PACEMAKER WAS ELECTIVELY EXPLANTED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4055

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L| R 4054| 1488TC| 1298| 4055