BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 2173288 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10823
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    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

    THE ASSOCIATED PULSE GENERATOR WAS NOT EXPECTED FOR RETURN AS THE HOSPITAL KEEPS THE DEVICES. THIS RV LEAD WAS SURGICALLY ABANDONED. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A ROUTINE OULSE GENERATOR CHANGEOUT. THE BEGINNINGS OF FRACTURE WERE NOT EVIDENT OR ALLEGED PRIOR TO THE DEVICE CHANGEOUT, ALTHOUGH THERE HAD BEEN UPWARD TRENDING OF THRESHOLD MEASUREMENTS OVER TIME. THE BOSTON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE CONFIRMED THAT THERE HAD BEEN NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR S606| MISMATCH| 1297| 4035| 4087