BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3991299 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02163
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 2, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. 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. 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: SURGICAL LEAD EXTRACTION FOR TOTAL OCCLUSION OF THE SUPERIOR VENA CAVA BY CHRONIC LEAD INFECTION AFTER MUSTARD PROCEDURE. J. CARD. SURG. 2014;29(3):406-409. AN EMAIL WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF YET. PRODUCT ID: 4068 X 2, IMPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THESE IMPLANTABLE PULSE GENERATORS (IPG) AND LEADS. THE PATIENT EXPERIENCED CHRONIC PACEMAKER INFECTION REQUIRING SIX SURGICAL INTERVENTIONS. DURING THE EXPLANT OF THE IPG SYSTEM THE VENTRICULAR LEAD FRACTURED AND THE DISTAL PORTION WAS LEFT IN PLACE. THE IPG SYSTEM WAS REPLACED WITH A NEW IPG SYSTEM AND WITH A ROUTINE REPLACEMENT OF THE IPG SYSTEM A LEAD RELATED INFECTION WAS FOUND ON THE RIGHT SIDE. BLOOD CULTURES WERE NEGATIVE, HOWEVER, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED LARGE VEGETATION ON THE VENTRICULAR LEAD. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE IPG SYSTEM WAS EXPLANTED AND ONCE AGAIN THE VENTRICULAR LEAD FRACTURED NECESSITATING ABANDONMENT OF THE DISTAL PART OF THE LEAD. BLOOD CULTURES REMAINED NEGATIVE; HOWEVER, THERE REMAINED AN ACTIVE LEAD INFECTION, ENDOCARDITIS AND MEDIASTINITIS. THE LEAD PORTIONS WERE REMOVED VIA A CARDIOPULMONARY BYPASS PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472032 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN RICE CREEK MFG 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Hospitalization| R 7088 IPG IMPLANT UNK