BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 9927691 · Received April 6, 2020

    Report

    Report Number
    2649622-2020-07031
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 22, 2020
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124812
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4351-35 GASTRIC MGU LEAD, IMPLANT DATE (B)(6) 2019; 4351-35 GASTRIC MGU LEAD, IMPLANT DATE (B)(6) 2019; 37800 GASTRIC MGU IPG, IMPLANT DATE (B)(6) 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. 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 EXPERIENCED ENDOCARDITIS. VEGETATION WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS INTUBATED AND RECEIVED PHARMACOLOGICAL INTERVENTION. THE COMPLETE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392155 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00681490124812

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 407645 LEAD, ADDRL1 IPG