BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1875212 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11639
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    May 4, 2010
    Report Date
    February 28, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. IT WAS ALSO NOTED WITH ANALYSIS THAT THE GROMMET WAS DAMAGED AND THE SET SCREW WAS LODGED AND LOOSE/DETACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPOSITION OF THE ATRIAL LEAD THIS IMPLANTABLE PULSE GENERATOR (IPG) HAD AN ATRIAL SETSCREW MISSING. SUBSEQUENTLY THE DEVICE WAS EXCHANGED BY ANOTHER. IT WAS FURTHER REPORTED THAT THE TWO LEADS WERE REPOSITIONED BECAUSE OF HIGH THRESHOLDS DISCOVERED DURING A STANDARD CHECK-UP THREE DAYS AFTER IMPLANT. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention