BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI

    MDR report key: 2954854 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01350
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    May 17, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. HOWEVER, THE HELIX WAS BENT /PULLED/STRETCHED/OVERSTRESSED. THERE WAS APPARENT EXPLANT DAMAGE.

    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: 5086MRI IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND THE RIGHT ATRIAL (RA) LEADS DISLODGED. THE PATIENT HAD HAD AN ABLATION PROCEDURE A FEW MONTHS AFTER THE IMPLANT. THE PATIENT ALSO COMPLAINED OF THE DEVICE "MOVING AROUND" IN THE POCKET. BOTH LEADS WERE EXPLANTED AND REPLACED. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59184 CAPSUREFIX MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R RVDR01 IMPLANTABLE PULSE GENERATOR