BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964670 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01890
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    February 20, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PRODUCTS 4076 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED DURING ROUTINE FOLLOW UP WITH HIGH IMPEDANCE AND NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. TREND DATA INDICATED THAT THE LEAD HAD MODE SWITCHED FROM BIPOLAR TO UNIPOLAR PACING. AN X-RAY CONFIRMED THAT THERE WAS INSULATION DAMAGE AND FRACTURE BELOW THE PATIENT'S CLAVICLE. THE RV LEAD WAS CAPPED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, PRIOR TO IMPLANT, THE RV LEAD WAS TESTED OUTSIDE OF THE PATIENT AND FOUND THAT THE HELIX HAD A JERKY MOTION AND DID NOT EXTEND OR RETRACT SMOOTHLY ALSO REQUIRED MANY TURNS TO EXTEND OR RETRACT. THE RV LEAD WAS NOT USED AND A DIFFERENT RV LEAD WAS IMPLANTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67456 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)