BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4766620 · Received May 12, 2015

    Report

    Report Number
    2182208-2015-01445
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 22, 2015
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    LWP
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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. REFERENCED ARTICLE: IMPLANTATION OF PERMANENT PACEMAKER AND ICD LEADS IN CHILDREN USING A THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEM AS AN AID TO FLUOROSCOPY. PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2015;38(4):448-454. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT'S IMPLANTABLE PULSE GENERATOR¿S (IPG) ATRIAL LEAD. THE ARTICLE REFERENCES THAT ¿SEVERAL HOURS AFTER THE [IMPLANT] PROCEDURE¿ THE ATRIAL LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED WITHOUT ANY COMPLICATIONS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310472 CAPSUREFIX MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, PLC 5086

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Required Intervention IMPLANTABLE PULSE GENERATOR (IPG)