BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 8811722 · Received July 22, 2019

    Report

    Report Number
    2182208-2019-01320
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 22, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. 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. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/68 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: BIPOLAR ACTIVE FIXATION LEFT VENTRICULAR LEAD OR QUADRIPOLAR PASSIVE FIXATION LEAD? AN ITALIAN MULTICENTER EXPERIENCE. JOURNAL OF CARDIOVASCULAR MEDICINE (HAGERSTOWN, MD.). 2019. 20(4):192-200. DOI: 10.2459/JCM.0000000000000778. 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 A COMPARISON BETWEEN IMPLANTS OF A BIPOLAR ACTIVE FIXATION LEFT VENTRICULAR (LV) LEAD, AND A QUADRIPOLAR PASSIVE FIXATION LEAD. MULTIPLE EVENTS INVOLVING THE BIPOLAR ACTIVE FIXATION LEADS INCLUDED: FOUR (4) DISLODGEMENTS, TWO (2) OF WHICH WERE REPLACED BEFORE HOSPITAL DISCHARGE AND TWO (2) THAT MIGRATED TO ANOTHER STABLE LOCATION AND REMAINED ACTIVE DESPITE SUBOPTIMAL PACING PARAMETERS; FOUR (4) THAT RESULTED IN INFECTION AND SUBSEQUENT EXTRACTION AND AN OBSERVATION THAT THE HELICES APPEARED ELONGATED UPON EXPLANT; AND TWO (2) CASES OF PHRENIC NERVE STIMULATION, TWO (2) OF WHICH WERE REVISED AND TWO (2) THAT WERE REPROGRAMMED. EVENTS INVOLVING THE QUADRIPOLAR PASSIVE FIXATION LEADS INCLUDED: SEVEN (7) CASES OF UNSTABLE LEAD POSITION DURING IMPLANT, ALL OF WHICH WERE SUBSEQUENTLY REPLACED WITH BIPOLAR ACTIVE FIXATION LEADS; AND FIVE (5) CASES OF DISLODGEMENT AFTER HOSPITAL DISCHARGE, TWO (2) OF WHICH WERE REPOSITIONED, AND TWO (2) WERE REPLACED WITH A DIFFERENT MODEL. THE ARTICLE ALSO INDICATED 18 DEATHS DUE TO ALL-CAUSE-MORTALITY. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE STATUS OF SOME OF THE LEADS ARE 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
    604391 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R CRTD