BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 3964997 · Received July 29, 2014

    Report

    Report Number
    2124215-2014-14623
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT ATRIAL (RA) LEAD SYSTEM EXHIBITED HIGH, OUT OF RANGE, PACING LEAD IMPEDANCE MEASUREMENT OF GREATER THAN 2,000 OHMS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE WAS PROGRAMMED TO VVIR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440793 SWEET TIP IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 4047| 7276| N141| 0125| (B)(4)| 0049| 0067| N119| MISMATCH| 6835| 6721M| 4968| 4269| 4193| 1853| 1810| 1720| 5076| 6933| 6943| 0115