BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1991282 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02326
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE CLINIC AFTER RECEIVING TWO SHOCKS. LEAD FRACTURE WAS SUSPECTED AS VTIP-VRING ELECTROGRAM (EGM) NOISE WAS PRESENT DURING MANIPULATION WHEN LEAD WAS CONNECTED TO THE ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR). AN ATTEMPTED LEAD REPLACEMENT WAS PERFORMED BECAUSE ANALYZER MEASUREMENTS REVEALED HIGH RIGHT VENTRICULAR (RV) LEAD IMPEDANCE DURING INTERVENTION, HOWEVER THE LEAD WAS SURROUNDED MY TISSUE, THE LEAD (MODEL 6944) WAS CAPPED AND LEFT IN THE PATIENT. NO FURTHER 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD