BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3399613 · Received October 9, 2013

    Report

    Report Number
    2182208-2013-02947
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 22, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. CORRESPONDENCE WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF THE TIME OF THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: CUI K, FENG Y, LI X, FANG Y. PERCUTANEOUS TRANSHEPATIC VENOUS ACCESS FOR ICD IMPLANTATION IN A PATIENT WITH EBSTEIN'S ANOMALY WITH VENTRICULAR TACHYCARDIA POST-GLENN OPERATION. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. JULY 1 2013;24(7):832-833. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS RIGHT VENTRICULAR (RV) LEAD. TWO MONTHS AFTER THE LEAD WAS IMPLANTED, THE AUTOMATIC ALERT SOUNDED FOR LOW IMPEDANCE; HOWEVER, THE ARTICLE INDICATED THIS ALERT WAS "IGNORED." THEN AT THE SIX-MONTH FOLLOW UP VISIT, RADIOGRAPHS OF THE CHEST AND ABDOMEN INDICATED THAT THE LEAD HAD DISLOCATED INTO THE RIGHT ATRIUM. THE ARTICLE STATED THAT THIS WAS DUE TO THE "DAILY PHYSICAL ACTIVITY OF THE PATIENT." THE TESTING WAS DONE AND THE APPROPRIATE SHOCK WAS DELIVERED TO TERMINATE THE INDUCED VENTRICULAR FIBRILLATION (VF). THE LEAD REMAINS IN USE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THE EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511855 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Hospitalization| R