BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3990179 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08747
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS REVEALED NO ANOMALIES. HOWEVER, TTHE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. CONCOMITANT: OTHER PRODUCT: 419688 CRDM NON-DEFIB LEAD IMPLANTED: 2014-(B)(6); 407652 CRDM NON-DEFIB LEAD IMPLANTED: 2014-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN ACCIDENTALLY PUT A SUTURE THROUGH THE LEAD. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464428 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R DTBA1D4 BIV ICD