BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1072732 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03506
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    March 4, 2008
    Report Date
    April 25, 2018
    Manufacturer
    MPRI
    Product Code
    LWS
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING EXTRACTION OF THE RIGHT VENTRICULAR (RV) LEAD, A LOCKING STYLET COULD NOT BE ADVANCED TO THE LEAD. DURING EXTRACTION OF THE LEAD, THE LEAD BROKE PRIOR TO THE PROXIMAL COIL AND WAS NOT COMPLETELY ENDOVASCULAR. THE LEAD WAS CAPTURED WITH A DEFLECTABLE WIRE AND GOOSE NECK SNARE. THE PROXIMAL COIL WAS PULLED DOWN FROM THE SUPERIOR VENA CAVA (SVC) BUT THE LEAD BROKE AGAIN BETWEEN THE SVC AND RV COILS. THE PROXIMAL PORTION OF THE LEAD, INCLUDING THE SVC COIL WAS REMOVED VIA THE FEMORAL WORKSTATION. THEN A SECOND FEMORAL WORKSTATION WAS INSERTED TO SNARE THE DISTAL PORTION OF THE LEAD WHICH WAS REMOVED BY ADVANCING THE FEMORAL WORKSTATION TO THE DISTAL PORTION OF THE LEAD. VERY HEAVY FIBROSIS WAS NOTED AT THE TIP OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6942 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R| R 5076 IMPLANTABLE PACING LEAD