BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3993456 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09303
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. PRODUCTS: 507652 LEAD IMPLANTED: 2014 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE EXPOSED RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/ STRETCHING/ OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH THE RV EXPOSED COIL EXTRINSIC DISTORTION STRETCHED. THIS IS A RESULT OF ATTEMPTED IMPLANT DAMAGE AND IS NOT CONSIDERED A LEAD FAILURE.

    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 REPORTED THAT DURING AN ATTEMPTED IMPLANT, THE PHYSICIAN WAS UNABLE TO PASS THE RIGHT VENTRICULAR (RV) LEAD THROUGH THE PATIENT'S TORTUOUS SUPERIOR VENA CAVA (SVC) AFTER MULTIPLE ATTEMPTS. THE RV LEAD WAS REMOVED AND EXAMINED, IN WHICH IT WAS DETERMINED THAT THE HELIX WOULD NOT DEPLOY. MULTIPLE ATTEMPTS WERE MADE TO CLEAN THE DISTAL TIP WITH SALINE FLUSH AND A SMALL NEEDLE, HOWEVER, THE HELIX WOULD STILL NOT DEPLOY. THE PHYSICIAN ELECTED TO ATTEMPT A NEW RV LEAD, HOWEVER, THIS LEAD WAS UNABLE TO BE PASSED THROUGH THE SVC EITHER AFTER MULTIPLE ATTEMPTS. THE SECOND RV LEAD WAS REMOVED AND EXAMINED, WHICH REVEALED QUESTIONABLE COIL SEPARATION. THE PHYSICIAN ELECTED TO USE A NEW RV LEAD TO IMPLANT SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469545 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR DDBB1D4 ICD