BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2205307 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01394
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. REFERENCED ARTICLE: "UNEXPECTED PACING INHIBITION UPON EXPOSURE TO THE 3T STATIC MAGNETIC FIELD PRIOR TO IMAGING ACQUISITION: WHAT IS THE MECHANISM?" HEART RHYTHM. 2011;8(6):944-945.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH "SEVERE HEADACHES." THE PATIENT WAS SCHEDULED FOR A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. THE PATIENT'S DEVICE WAS PRE-PROGRAMMED PRIOR TO THE PROCEDURE TO HAVE ALL TACHYCARDIA THERAPIES "OFF." THERE WAS "UNEXPECTED PACING INHIBITION" NOTED PRIOR TO ANY APPLICATION OF RADIOFREQUENCY (RF) OR GRADIENT MAGNETIC FIELDS. THE PATIENT'S RHYTHM REMAINED STABLE, SO THE PROCEDURE WAS CONTINUED. PACING REMAINED INHIBITED DURING AND AFTER RF AND GRADIENT FIELD APPLICATION. ONCE THE PATIENT WAS REMOVED FROM THE MRI BORE, PACING RESUMED. THE PACING INHIBITION RETURNED AGAIN PRIOR TO ANY APPLICATION OF RF OR GRADIENT FIELDS PRIOR AND DURING THE CONTRAST PHASE OF IMAGING. UPON COMPLETION OF ALL SCANNING, PACING RETURNED TO PROGRAMMED SETTINGS. 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 SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| O| R