BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 6847520 · Received September 6, 2017

    Report

    Report Number
    2182208-2017-01429
    Event Type
    Death
    Date Received
    September 6, 2017
    Date of Event
    May 17, 2004
    Report Date
    August 7, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. MULTIPLE PATIENTS AND MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER DEVICE/PRODUCT FAILURE CORRELATION/SERIAL NUMBERS. THE GENDER OF THE BASELINE CHARACTERISTICS IS FEMALE AND THE BASELINE AGE IS APPROXIMATELY 3.8 MONTHS OLD. POSSIBLE MODELS COULD INCLUDE SX 5985, 204, 203, 201, SR 8960 I, DIAMOND II. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT, AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. 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: ENDOCARDIAL PACEMAKER IMPLANTATION IN INFANTS WEIGHING <(><<)>= 10 KILOGRAMS. PACE 2004;27:1466-1474. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PACING LEADS AND IMPLANTABLE PULSE GENERATORS (IPG) WITH ENDOCARDIAL IMPLANTATION. 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 AND PATIENTS WHO EXPERIENCED SKIN NECROSIS, INFECTION, ENDOCARDITIS, LEAD DAMAGE, HIGH THRESHOLDS, AND LOW IMPEDANCE. THE STATUS OF THE DEVICE AND LEADS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624134 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Death| H| R MDT LEAD