BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3151765 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05632
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THE OUTER INSULATION WAS CUT. IT WAS ALSO NOTED THAT THERE WAS BLOOD ON THE OVERLAY TUBING, THE HELIX WAS BENT, AND THE LEAD WAS DAMAGED AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING INTERMITTENT OVERSENSING POST POCKET CLOSURE. OVERSENSING COULD NOT BE REPRODUCED WITH POCKET MANIPULATION. THE POCKET WAS REOPENED AND A SOLID CONNECTION WAS CONFIRMED BETWEEN THE LEAD AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW RV LEAD. IT WAS FURTHER NOTED THAT THE EXPLANTED LEAD MAY HAVE BEEN CUT BY THE SCALPEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252749 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R D314DRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR