BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2122553 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07883
    Event Type
    Injury
    Date Received
    June 13, 2011
    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. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: "INAPPROPRIATE SHOCK DELIVERY BY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DUE TO ELECTRICAL LEAK FROM BATHROOM TAP." CLIN. RES. CARDIOL. NOVEMBER 1;99(11):761-763. SERIAL NUMBERS HAVE BEEN ADDED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS DEVICE AND LEAD. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE SHOCKS. DEVICE INTERROGATION REVEALED TYPICAL EMI. THE PATIENT WAS PREPARING TO WASH HIS HANDS IN THE BATHROOM AND TOUCHED THE TAP WITH HIS WET LEFT HAND SHORTLY BEFORE THE SHOCK. THE PATIENT REMAINED ASYMPTOMATIC BEFORE AND AFTER THE SHOCK. THE EGM REVEALED NOISE. AN ELECTRICIAN INSPECTED THE BATHROOM TAP AND A "SMALL AMOUNT OF CURRENT LEAK WAS DETECTED." THE ELECTRICIAN FOUND THE LEAK ORIGINATED FROM AN "INAPPROPRIATELY EARTHED BATHROOM SOCKET." THE SOCKET WAS REGROUNDED. IT APPEARS THE DEVICE AND LEAD ARE STILL IN USE. FURTHER FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. 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 77 YR Hospitalization| L| R