BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2964868 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02014
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS FOUND THE HELIX WAS BENT. BLOOD WAS NOTED ON THE DISTAL ELECTRODE AND THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT. CONCOMITANT PRODUCTS: 1258T COMPETITOR IMPLANTABLE PACING LEAD 2010 (B)(6), 5076 IMPLANTABLE PACING LEAD 2010 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ELEVATED THRESHOLD ON THE NEWLY IMPLANTED LEAD. X-RAY CONFIRMED THE LEAD DISLODGED. A LEAD REPOSITION WAS ATTEMPTED BUT THE DOCTOR WAS UNABLE TO RETRACT THE HELIX. IT WAS NOTED A CHUNK OF TISSUE WAS REMOVED FROM THE BASE OF THE HELIX FOLLOWING LEAD EXTRACTION THAT WAS SUSPECTED TO HAVE BEEN JAMMING THE HELIX MECHANISM. THE HELIX MECHANISM WAS DEMONSTRATED TO BE WORKING WELL FOLLOWING REMOVAL OF THIS TISSUE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67324 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR