BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 8021273 · Received October 30, 2018

    Report

    Report Number
    2182208-2018-01980
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    July 17, 2018
    Report Date
    October 30, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/62 YEARS OLD. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/DEVICE SERIAL NUMBERS. 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. POSSIBLE MODELS COULD INCLUDE THE FOLLOWING LEAD MODELS 5554, 5076, 4574, AND 6935M. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: MECHANISTIC IMPLICATION OF DECREASED PLASMA ATRIAL NATRIURETIC PEPTIDE LEVEL FOR TRANSIENT RISE IN THE ATRIAL CAPTURE THRESHOLD EARLY AFTER ICD OR CRT-D IMPLANTATION. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2018; 53(1):131-140. DOI: 10.1007/S10840-018-0409-0. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE PACING LEADS. IT WAS REPORTED THAT WAS "GRADUAL PACING IMPEDANCE DECREASE NOTED DURING THE FOLLOW UP PERIOD." ADDITIONALLY, THERE WERE THREE PATIENTS WITH PERSISTENT RATHER THAN TRANSIENT RISE IN THE ATRIAL CAPTURE THRESHOLD AND TWO PATIENTS WITH PERSISTENT RATHER THAN TRANSIENT VENTRICULAR CAPTURE THRESHOLD. OF NOTE, THERE WAS NO TREATMENT/RESOLUTION INDICATED. THE STATUS OF THE LEADS 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
    862143 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other