BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO VR

    MDR report key: 4387919 · Received January 6, 2015

    Report

    Report Number
    2182208-2015-00005
    Event Type
    Death
    Date Received
    January 6, 2015
    Date of Event
    January 1, 2014
    Report Date
    January 23, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER DEATH-DEVICE/PRODUCT FAILURE CORRELATION. THE DATE OF DEATH FOR THE MISCARRIAGES AND STILLBIRTH IS PURELY AN ESTIMATE, AS THERE IS NO DIRECT INDICATION OF MEDTRONIC-DEVICE PATIENT DEATHS. THE BASELINE AGE IS 28 YEARS OLD. REFERENCED ARTICLE: PREGNANCY IN WOMEN WITH AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR: IS IT SAFE? EUROPACE. 2014;16(11):1587-1594. (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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER DEATH-DEVICE/PRODUCT FAILURE CORRELATION. THE DATE OF DEATH FOR THE MISCARRIAGES AND STILLBIRTH IS PURELY AN ESTIMATE, AS THERE IS NO DIRECT INDICATION OF MEDTRONIC-DEVICE PATIENT DEATHS. 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: PREGNANCY IN WOMEN WITH AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR: IS IT SAFE? EUROPACE. 2014;16(11):1587-1594. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT MISCARRIAGES AND A STILLBIRTH WERE REPORTED. THE ARTICLE FURTHER INDICATED THAT ONE PATIENT HAD EXPERIENCED T-WAVE OVERSENSING (TWOS) AND HAD AN INAPPROPRIATE SHOCK WHICH ¿MIGHT HAVE CAUSED THE MISCARRIAGE.¿ FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. THE CAUSE OF THE FETAL DEATHS AND DEVICE RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT MISCARRIAGES AND A STILLBIRTH WERE REPORTED. THE ARTICLE FURTHER INDICATED THAT ONE PATIENT HAD EXPERIENCED T-WAVE OVERSENSING (TWOS) AND HAD AN INAPPROPRIATE SHOCK WHICH ¿MIGHT HAVE CAUSED THE MISCARRIAGE.¿ THE CAUSE OF THE FETAL DEATHS AND DEVICE RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THERE WAS NO SURGICAL INTERVENTION SCHEDULED FOLLOWING THE ICD SHOCKS. THE PATIENT WAS ADVISED TO COMPLY WITH HER BETA-BLOCKER THERAPY. THE PATIENT IS STILL ALIVE. THE AUTHOR STATED: "AS INDICATED IN THE MANUSCRIPT, THE CAUSAL RELATIONSHIP BETWEEN ICD SHOCKS AND SUBSEQUENT MISCARRIAGE IN THIS PATIENT CANNOT BE ASSESSED IN A CONCLUSIVE MANNER. NO FETAL MONITORING WAS PERFORMED IN THIS PATIENT BETWEEN ICD SHOCKS AND MISCARRIAGE. AS EXPOSED IN THE PAPER, WE ACKNOWLEDGE THAT THIS MISCARRIAGE MAY BE TOTALLY UNRELATED TO ICD SHOCKS AND SIMPLY BE AN IDIOPATHIC MISCARRIAGE AS IT IS FREQUENTLY SEEN IN THE GENERAL POPULATION. THIS POINT IS DISCUSSED IN DETAILS IN THE SECTION ¿ICD SHOCK THERAPY DURING PREGNANCY¿. THAT HAVING BEEN SAID, WE BELIEVE THAT REPORTING THIS CASE WAS NONETHELESS OF CERTAIN INTEREST, AS ICD SHOCKS DURING SUCH AN EARLY STAGE OF PREGNANCY HAD NOT BEEN REPORTED SO FAR, SO THAT THEIR CONSEQUENCES ON FETAL OUTCOME REMAINS TOTALLY UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7880 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 7232

    Patients

    Seq Age Sex Outcome Treatment
    1 Death