BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1861810 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10087
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 6, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) DISTAL CONDUCTOR FRACTURED. THE DEFIB CONDUCTOR WAS DISTORTED. THERE WAS BLOOD/BODY FLUID IN/ON HELIX MECHANISM (SLEEVE HEAD), OUTER TUBING OVERLAY AND SEVERAL CONDUCTORS (NOT OBSTRUCTED). OUTER TUBING OVERLAY MELTED. DISTAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL BECAUSE THE PATIENT ALARM SOUNDED. INTERROGATION OF THE ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) REVEALED 3305 SHORT VV INTERVALS SINCE PREVIOUS DAY. THE PHYSICIAN DECIDED TO TURN OFF THE THERAPIES. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT DID NOT RECEIVE ANY INAPPROPRIATE SHOCKS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention