BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE

    MDR report key: 3212940 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10626
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 28, 2013
    Report Date
    August 5, 2013
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED MISSING THE DISTAL TIP. VISUAL INSPECTION CONFIRMED THAT THE COILS AT THE DISTAL REGION OF THE RETURNED SEGMENT WERE EXTREMELY STRETCHED, LIKELY DUE TO PULLING DURING LEAD EXPLANT. SET SCREW MARKS WERE NOTED ON THE TERMINAL PIN AND TERMINAL RING. FURTHER TESTING INDICATED THE LEAD PASS THE DIRECT CURRENT MEASUREMENT TEST.

    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

    THE LEAD WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS NOTED TO BE NON-FUNCTIONING, WITH LOSS OF CAPTURE (LOC) AND INCREASED THRESHOLD MEASUREMENTS. THE DEVICE WAS REPROGRAMMED TO AAI. A REVISION PROCEDURE WAS PERFORMED DUE TO THE DEVICE REACHING ELECTIVE REPLACEMENT INDICATOR (ERI). THIS LEAD WAS EXTRACTED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313260 SELUTE IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4285

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R MISMATCH| 1270| 4456| 4285| 4269| 4470| K173| 4136| S603| 1230