BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3860590 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05378
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY -THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5086MRI52, LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INTERMITTENT NON-CAPTURE. THE RV LEAD WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD HAD SMALL P-WAVES. DURING THE EXPLANT OF THE LEAD, THE HELIX WOULD NOT RETRACT WITH ROTATION. THE WHOLE BODY OF THE LEAD WAS THEN ROTATED AND EXPLANTED. TISSUE WAS NOTED AT THE TIP/HELIX. THE LEAD WAS THEN REPLACED. FOLLOWING THE ATRIAL LEAD REMOVAL, AN ECHOCARDIOGRAM SUGGESTED TAMPONADE. PERIOCARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340147 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| L| R RVDR01 IPG