BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 6828290 · Received August 29, 2017

    Report

    Report Number
    2182208-2017-01411
    Event Type
    Death
    Date Received
    August 29, 2017
    Date of Event
    January 1, 2001
    Report Date
    August 1, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT MODEL/SERIAL NUMBERS. THE MODEL LISTED IN THE PLI IS A REPRESENTATIVE, AS THERE IS NO SPECIFIC MODEL LISTED WITH SPECIFIC PRODUCT PROBLEMS/ADVERSE EVENTS. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT AND THERE IS NO DIRECT CORRELATION WITH DEVICE LOT/SERIAL/MANUFACTURERS NUMBERS. THE BASELINE AGE/WEIGHT CHARACTERISTIC IS (B)(6) FOR THE PATIENTS REFERENCED IN THE ARTICLE. 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: ¿PERMANENT EPICARDIAL PACING IN PEDIATRIC PATIENTS SEVENTEEN YEARS OF EXPERIENCE AND 1200 OUTPATIENT VISITS.¿ CIRCULATION. 2001; 103:2585-2590. 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 PULSE GENERATOR (IPG) SYSTEMS. MULTIPLE PATIENTS AND MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE/MANUFACTURER SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE PATIENT DEATHS; THE CAUSE OF DEATH AND DEVICE-RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED. THERE WERE ALSO PATIENTS WHO HAD POCKET INFECTIONS, CELLULITIS, BACTEREMIA, ¿POSTPERICARDIOTOMY SYNDROME,¿ PLEURAL EFFUSION, FEVER, EXIT BLOCK, PHRENIC NERVE STIMULATION, AND ¿EXACERBATION OF PROTEIN-LOSING ENTEROPATHY AFTER A THORACOTOMY FOR PACEMAKER IMPLANTATION.¿ THERE WERE ALSO APPARENT LEAD FRACTURES, INAPPROPRIATE SENSING, AND INCREASING PACING THRESHOLDS. THE ARTICLE INDICATED THAT SOME OF THE MEDICAL/SURGICAL INTERVENTIONS TAKEN WERE EARLY AND/OR LATE HOSPITAL RE-ADMISSIONS, SYSTEM REMOVALS, ANTIBIOTICS ADMINISTERED, AND ABANDONMENT OF LEADS. THE STATUS/LOCATION OF THE SYSTEM IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607280 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Death| H| L| R IMPLANTABLE PACING LEAD