BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 10437962 · Received August 21, 2020

    Report

    Report Number
    2182208-2020-01593
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    January 1, 2001
    Report Date
    August 21, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS. THE OVERALL BASELINE GENDER CHARACTERISTICS IS MALE; THE AGE OF THE PATIENTS WAS APPROXIMATELY 56 YEARS OLD. POSSIBLE MODELS COULD INCLUDE THE FOLLOWING: TRANSVENEE-RV-6936 LEAD, TRANSVENEE-SVC-6933, TRANSVENEE-RV-6939. 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: ¿COMPARISON OF THE EFFICACY OF A SUBCUTANEOUS ARRAY ELECTRODE WITH A SUBCUTANEOUS PATCH ELECTRODE, A PROSPECTIVE RANDOMIZED STUDY.¿ INTERNATIONAL JOURNAL OF CARDIOLOGY 78 (2001) 247¿256. DOI: 10.1016/S0167-5273(01)00381-3. 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 SUBCUTANEOUS PATCH ELECTRODE LEADS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE ARTICLE INDICATED THAT FOUR (4) PATIENTS EXPERIENCED COMPLICATIONS POST-OPERATIVELY: TWO (2) PATIENTS HAD A ¿SUBSTANTIAL¿ HEMATOMA, BOTH OF WHICH WITH UNKNOWN TREATMENT/RESOLUTION; ONE (1) PATIENT HAD THE LEAD REMOVED DUE TO ¿SEVERE¿ PAIN IN THE AREA SURROUNDING THE PATCH; AND ONE (1) PATIENT SUFFERED ¿RECURRENT¿ SEROMA IN THE AREA OF THE PATCH. 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
    903400 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention