BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3151678 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05652
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 2, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 LEAD WAS RETURNED IN SEGMENTS, ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING, THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR, THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, THE OUTER INSULATION OF THE LEAD DEVELOPED A COSMETIC DEPRESSION WHILE IN VIVO, THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO, THE OUTER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, THE OVERLAY TUBING OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE AND STRETCHING. CONCOMITANT MEDICAL PRODUCTS: D224TRK, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), (B)(6) 2010; 4076, IMPLANTABLE PACING LEAD, (B)(6) 2010; 4195, IMPLANTABLE PACING LEAD, (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD CHRONICALLY HIGH THRESHOLDS AND THE IMPEDANCE HAD RISEN FOR 3 DAYS AND THEN WENT BACK DOWN. A LEAD INTEGRITY ALERT TRIGGERED ON THE BASIS OF MANY NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES WHICH APPEARED TO BE NOISE. THERE HAD BEEN 79 V-V SHORT INTERVAL COUNTS (SIC) IN THE PAST TWO DAYS. A LEAD FRACTURE WAS SUSPECTED. 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
    253178 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R