BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 4161610 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02654
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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: PREDICTIVE IMPACT OF THE DECREASING RATE OF INTRATHORACIC IMPEDANCE IN WORSENING CHRONIC HEART FAILURE. J. INTERVENT. CARD. ELECTROPHYSIOL. 2014;40(1):87-91. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ARTICLE STUDIED THE INTRATHORACIC IMPEDANCE CHANGES IN PATIENTS WITH AND WITHOUT HEART FAILURE. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THERE WERE ¿UNEXPLAINED EPISODES¿ OF IMPEDANCE CHANGES. THE ARTICLE FURTHER INDICATED THAT THERE WERE 129 ¿FLUID INDEX THRESHOLD CROSSING EVENTS IN TOTAL,¿ SOME OF WHICH WERE DUE TO PNEUMONIA. THE STATUS OF THE DEVICE IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THERE WERE NO COMPLAINTS OR MALFUNCTIONS NOTED FOR THE DEVICES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ARTICLE STUDIED THE INTRATHORACIC IMPEDANCE CHANGES IN PATIENTS WITH AND WITHOUT HEART FAILURE. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THERE WERE ¿UNEXPLAINED EPISODES¿ OF IMPEDANCE CHANGES. THE ARTICLE FURTHER INDICATED THAT THERE WERE 129 ¿FLUID INDEX THRESHOLD CROSSING EVENTS IN TOTAL,¿ SOME OF WHICH WERE DUE TO PNEUMONIA. THE STATUS OF THE DEVICE IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642039 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE LWS MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R IMPLANTABLE TACHY LEAD