BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA

    MDR report key: 3212992 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10676
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    November 8, 1988
    Report Date
    July 10, 2013
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ONGOING. THIS REPORT WILL BE UPDATED PENDING ANALYSIS COMPLETION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE SAME DAY THIS DEVICE WAS IMPLANTED, ATRIAL AND VENTRICULAR CHANNELS EXHIBITED LOSS OF CAPTURE (LOC) WHEN THE PATIENT SHIFTED IN THE HOSPITAL BED. A REVISION PROCEDURE WAS PERFORMED. UPON OPENING THE DEVICE POCKET, THE FACE OF THE DEVICE WAS NOT MAKING GOOD CONTACT WITH THE PATIENT'S SKIN. ADDITIONALLY, AN ABANDONED LEAD WAS NOTED TO BE BETWEEN THE DEVICE AND SKIN, CREATING A TENTING AFFECT, LIMITING THE CONTACT WITH THE SKIN. THE ABANDONED LEAD WAS CUT BACK AND SURGICALLY ABANDONED. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT THE PATIENT EXPIRED ON (B)(6) 1997. NO DEVICE ALLEGATIONS WERE ASSOCIATED WITH THE PATIENT'S DEATH. THE DEVICE WAS LATER RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313909 DELTA IMPLANTABLE PULSE GENERATOR NVZ HISTORICAL CPI ST. PAUL 0926

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 0635| 4260| 4270| 0926