BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALLINE

    MDR report key: 4161819 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02643
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 8, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: UPON FURTHER REVIEW, IT IS THIS MANUFACTURER'S BELIEF THAT THE REPLACEMENT PRODUCTS ARE THE ONES WITH THE SERIAL NUMBERS PROVIDED, WHICH WERE INADVERTENTLY ADDED TO THE FIRST SUPPLEMENTAL REPORT AND THE SUBSEQUENT REGULATORY REPORTS WERE SENT IN A TIMELY MANNER. THIS REPORT IS BEING SENT TO CORRECT THE DEVICES; REVERTING BACK TO THE CORRECT REPRESENTATION OF PRODUCTS IN THE INITIAL REGULATORY REPORT.

    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: LATE COMPLICATION OF HEART STIMULATION - LEAD ABRASION IN PACEMAKER POCKET. KARDIOLOGIA POLSKA. 2014;72(6):0022-9032. CONCOMITANT MEDICAL PRODUCTS: EN1DR01 IPG. (B)(4).

    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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: LATE COMPLICATION OF HEART STIMULATION - LEAD ABRASION IN PACEMAKER POCKET. KARDIOLOGIA POLSKA. 2014;72(6):0022-9032. CONCOMITANT PRODUCT: PRODUCT ID MDT-LEAD. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS MODEL OF IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS. A PATIENT PRESENTED WITH A REOCCURRENCE OF SYNCOPE FOUR YEARS AFTER PACEMAKER IMPLANTATION. THERE WAS NOTED PACING INHIBITION. THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE LEADS DUE TO "CRACKLES" SEEN AND LEAD "DAMAGE." THERE WAS LEFT-SIDE VENOUS OCCLUSION NOTED DURING THE LEAD REPLACEMENT PROCEDURE. UPON EXAMINATION OF THE LEADS, THERE WAS NOTED INSULATION ABRASION DUE TO "MUTUAL FRICTION." THE DEVICE WAS REPLACED PROPHYLACTICALLY DUE TO THE EJECTION FRACTION OF THE PATIENT. NEW LEADS WERE IMPLANTED AS WELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS MODEL OF IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS. A PATIENT PRESENTED WITH A RE-OCCURRENCE OF SYNCOPE FOUR YEARS AFTER PACEMAKER IMPLANTATION. THERE WAS NOTED PACING INHIBITION. THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE LEADS DUE TO "CRACKLES" SEEN AND LEAD "DAMAGE." THERE WAS LEFT-SIDE VENOUS OCCLUSION NOTED DURING THE LEAD REPLACEMENT PROCEDURE. UPON EXAMINATION OF THE LEADS, THERE WAS NOTED INSULATION ABRASION DUE TO "MUTUAL FRICTION." THE DEVICE WAS REPLACED PROPHYLACTICALLY DUE TO THE EJECTION FRACTION OF THE PATIENT. NEW LEADS WERE IMPLANTED AS WELL. ADDITIONAL INFORMATION WAS RECEIVED WHICH INCLUDED THE SERIAL NUMBERS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639510 CRYSTALLINE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI ICL08B45

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R 5086MRI52 LEAD