BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 6846730 · Received September 6, 2017

    Report

    Report Number
    2182208-2017-01428
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    January 1, 2012
    Report Date
    August 8, 2017
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. THE MODEL LISTED IN THE PLI IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED WITH SPECIFIC COMPLAINT; MODEL NUMBERS MAY INCLUDE: 5092, 5568, 5076. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿ABRASIONS OF THE OUTER SILICONE INSULATION OF ENDOCARDIAL LEADS IN THEIR INTRACARDIAC PART: A NEW MECHANISM OF LEAD-DEPENDENT ENDOCARDITIS.¿ EUROPACE (2012) 14, 903¿910. DOI:10.1093/EUROPACE/EUS003. 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 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 INDICATED THAT THERE WERE PATIENTS¿S LEADS REMOVED DUE TO INFECTIONS, POCKET INFECTIONS, ENDOCARDITIS, VENOUS/OCCLUSIONS, APPARENT FRACTURES, INSULATION DEGRADATION, FRAGMENTS LEFT IN THE PATIENT AFTER EXTRACTION, EXTERNALIZED LEAD CONDUCTORS, AND ¿NON-FUNCTIONING¿ LEADS. THE STATUS/LOCATION OF THE LEADS IS UNKNOWN; HOWEVER, THE ARTICLE INDICATED THAT THERE WERE LEADS EXTRACTED. 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
    625108 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, PLC MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R IMPLANTABLE PULSE GENERATOR (IPG)