BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3991388 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08140
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE DISTAL AND PROXIMAL CONDUCTORS OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. 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: RVDR01 IPG 2011-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD A POSSIBLE FRACTURE. IT WAS NOTED THAT THE PATIENT HAS HAD A FEW FALLS, MOST RECENT FALL CORRESPONDS WITH >3,000 LEAD IMPEDANCE OBSERVED BY CLINICIAN. AN IMPEDANCE OF 200 OHMS WAS NOTED A FEW MONTHS AGO, IN WHICH A FALL IS ALSO POSSIBLE BUT NOT COMPLETELY SURE FROM PATIENT AND WIFE. A CHEST X-RAY WAS NOT ORDERED. THE DECISION WAS TO MONITOR THE PATIENTSINCE NO SYMPTOMS WERE REPORTED AND PACING PERCENTAGE IS MINIMAL. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD CONTINUED TO HAVE HIGH IMPEDANCE AND THE LEAD WAS REPROGRAMMED DUE TO FRACTURE. THE LEAD WAS LATER EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469872 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 5086MRI58 LEAD