BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2801823 · Received October 23, 2012

    Report

    Report Number
    2124215-2012-14313
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 10, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ADMITTED TO THE HOSPITAL. THE PATIENT'S PHYSICIAN REPORTED THAT THE RA LEAD WAS DISPLAYING OVERSENSING AND THE RV LEAD WAS DISPLAYING NOISE. WHEN THE PATIENT WAS ADMITTED, THE DEVICE WAS PROGRAMMED VOO. THE PHYSICIAN ALSO REPORTED THAT THE PATIENT EXPERIENCED PACING INHIBITION WITH GREATER THAN TWO SECONDS OF ASYSTOLE. SUBSEQUENT INFORMATION FROM A COMPETITIVE FIELD REPRESENTATIVE INDICATED THAT THE PATIENT WAS SEEN FOR A REVISION PROCEDURE. THE CRT-D WAS EXPLANTED AND THE RA LEAD WAS CAPPED DUE TO A SUSPECTED INSULATION ISSUE. THE RV LEAD REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4064

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 0158| 4554| 4542| 4064| H227| 4034| 1280