BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, SJ4 CONNECTOR

    MDR report key: 1831121 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03582
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 1, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION.

    Description of Event or Problem · 1

    THE LAY REPORTER CONTACTED LFS ON (B)(6), 2010 ALLEGING INACCURATE HIGH READINGS ON HER FATHER'S ONE TOUCH ULTRAMINI METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON (B)(6), 2010 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT OBTAINED A RESULT OF 470 MG/DL ON THE LFS METER AT 11:00PM ON (B)(6), 2010. THE PATIENT THEN HIS USUAL DOSAGE OF MEDICATION (60 UNITS OF LANTUS) BASED ON THE METER RESULT OF 470 MG/DL AND ALSO TOOK AN UNSPECIFIED AMOUNT OF NOVOLOG INSULIN BASED ON THE METER READING. ON (B)(6), 2010 AT 10:00AM THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY, BLURRED VISION, SWEATY AND DIZZY. HE TESTED ON HIS DAUGHTER'S CONTOUR METER AND OBTAINED AN 85 MG/DL AND WAS TREATED WITH GLUCOSE TABLETS/GLUCOSE GEL BY HIS DAUGHTER. THE PATIENT DID NOT ATTEMPT TO TEST HIS BLOOD GLUCOSE USING THE LFS METER. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE DUE TO THE ALLEGED ISSUE. HE CLAIMS HE FELT BETTER AFTER TREATMENT. THE PRODUCT WAS REPLACED. PATIENT DENIED THAT THE TEST STRIPS WERE STORED INCORRECTLY AND CLAIMS THAT THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. A QUALITY CONTROL TEST WAS NOT DONE SINCE HE DID NOT HAVE ANY CONTROL SOLUTION. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE HIGH READING, HE TOOK INSULIN BASED ON THE METER RESULT AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO RECEIVE TREATMENT BY HIS DAUGHTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT PLUS DR, SJ4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 7121Q/58, (B)(4), 1888TC/52, (B)(4)