BEUDAMED
    FDA Adverse Event Death Summary report: N

    TWO IS-1 BI LEADS TO IS-1 BI IPG ADAPTOR KIT

    MDR report key: 4903765 · Received July 9, 2015

    Report

    Report Number
    2182208-2015-02220
    Event Type
    Death
    Date Received
    July 9, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 25, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTD
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND THE SUBSEQUENT FOLLOW UP INFORMATION OBTAINED FROM THE AUTHOR. THIS EVENT OCCURRED OUTSIDE THE U.S. 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 DEVICE/PRODUCT FAILURE CORRELATION OR DEATH-DEVICE RELATEDNESS INDICATED. THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). 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: LIMITATIONS OF CHRONIC DELIVERY OF MULTI-VEIN LEFT VENTRICULAR STIMULATION FOR CARDIAC RESYNCHRONIZATION THERAPY. J. INTERVENT. CARD. ELECTROPHYSIOL. 2015;42(2):135-142. (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 DEVICE/PRODUCT FAILURE CORRELATION OR DEATH-DEVICE RELATEDNESS INDICATED. THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6) YEARS OLD. 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: LIMITATIONS OF CHRONIC DELIVERY OF MULTI-VEIN LEFT VENTRICULAR STIMULATION FOR CARDIAC RESYNCHRONIZATION THERAPY. J. INTERVENT. CARD. ELECTROPHYSIOL. 2015;42(2):135-142. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH THE AUTHOR WHO INDICATED THAT THERE WERE ONLY TWO CASES WERE WITH THIS MANUFACTURER'S PRODUCT; IN ONE CASE THE PATIENT HAD DIED, BUT THE CAUSE IS UNKNOWN. THE AUTHOR FURTHER STATED THAT THERE WAS "NO REASON TO SUSPECT THAT THE LEADS CONTRIBUTED TO THIS DEATH." THE AUTHOR INDICATED THAT ALTHOUGH THERE WAS NO "MALFUNCTION" OF THE Y CONNECTOR, THERE WERE PROBLEMS WITH SENSING AND PACING. NO FURTHER 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 LEFT VENTRICULAR (LV) LEADS. 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 REPORTS THAT THERE WERE PATIENT DEATHS, AS WELL AS COMPLICATIONS/ALLEGATIONS LISTED AS CORONARY SINUS (CS) DISSECTION, PHRENIC NERVE STIMULATION (WHICH WAS NOT RESOLVED WITH REPROGRAMMING), LEAD REPOSITIONING, INCREASING THRESHOLDS, HIGH THRESHOLDS, NO CAPTURE, UNABLE TO DIFFERENTIATE BETWEEN THE LEADS, EROSION OF THE LEADS AND ADAPTOR, AND A REDUCTION IN IMPEDANCE. THE STATUS OF THE LEADS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. THE CAUSE OF DEATH AND DEVICE MANUFACTURER/RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447712 TWO IS-1 BI LEADS TO IS-1 BI IPG ADAPTOR KIT ADAPTOR, LEAD, PACEMAKER DTD MEDTRONIC, INC. 2872

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death| R