BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTHEM RF

    MDR report key: 1896755 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05402
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR FUNCTIONED NORMALLY, HOWEVER THE RIGHT VENTRICULAR, LEFT VENTRICULAR AND ATRIAL LEAD IMPEDANCE TREND HISTORY FROM THE DEVICE IMAGE REVEALED LOW OUT OF RANGE LEAD IMPEDANCES.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MERLIN.NET TRANSMISSIONS SHOWED EXTREMELY LOW LEAD IMPEDANCE MEASUREMENTS ON BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS. A DIAGNOSTICS ANOMALY WAS SUSPECTED. THE PULSE GENERATOR WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    PT REPORTED EXPERIENCING HYPOGLYCEMIA WHEN SHE AWAKENED FOR THE PAST 3 DAYS. PT STATED REVIEW OF THE INFUSION DEVICE MEMORY; IT SHOWED THE DEVICE DELIVERED A NEW BOLUS EVERY 30 MINUTES. PT REPORTED, THE INFUSION DEVICE HAS IMPLEMENTED SEVERAL BOLUSES DURING THE NIGHT WITHOUT THE PT HAVING HANDLED THE EQUIPMENT. PT STATED, SHE WENT TO THE DOCTOR TO REPORT THE INCIDENT, BUT NO DRUG WAS USED. PT REPORTED RECEIVING NO MEDICAL TREATMENT. PT REPORTED BLOOD GLUCOSE READINGS OF 47 MG/DL, 52 MG/DL AND 43 MG/DL. PT STATED, SHE HAS WELL CONTROLLED BLOOD GLUCOSE LEVELS. PATIENT'S NORMAL BLOOD GLUCOSE READING WAS NOT PROVIDED. ON FOLLOW UP CALL, REPORTER REPORTED, THE ISSUE ONLY OCCURRED THE NIGHT TIMES. REPORTER STATED, PT DID NOT UNDERSTAND THE INSTRUCTIONS THAT WERE GIVEN AT TRAINING. PT WAS REORIENTED TO BLOCK THE BUTTONS BEFORE GOING TO SLEEP. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTHEM RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION PM3210

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention