BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z

    MDR report key: 3860650 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05365
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    March 4, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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: 553453 IMPLANTABLE PACING LEAD, (B)(6) 1996. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED THAT ONE OF THEIR LEADS MAY NEED TO BE REPLACED, BUT THEY DID NOT SAY WHICH LEAD OR WHY IT NEEDED TO BE REPLACED. BOTH LEADS REMAIN IN USE. FOLLOW UP WAS ATTEMPTED FOR FURTHER INFORMATION, BUT WAS UNSUCCESSFUL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339292 CAPSURE Z ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5034-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR ADDR01 IPG