BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2953697 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01253
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 29, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    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: 5534 IMPLANTABLE PACING LEAD, (B)(6)1998. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOULDER INJURY WHILE DOG WALKING. AFTER THE INJURY, THE PATIENT BEGAN HAVING SYNCOPE AND NEAR SYNCOPE EPISODES. THE PATIENT WAS EVALUATED AND THE DEVICE EXHIBITED OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT UNDERWENT A PROCEDURE AND IT WAS DISCOVERED THAT THE PIN-PLUG WAS NOT FULLY SEATED INTO THE HEADER. THE LEAD WAS REINSERTED INTO THE HEADER AND SECURED VIA SET SCREWS. THE PATIENT THEN PRESENTED TO THE DOCTOR'S OFFICE COMPLAINING OF SYNCOPE AND NEAR SYNCOPE. THE DEVICE WAS INTERROGATED AND AGAIN OVERSENSING WAS DISCOVERED ON THE RV LEAD. THE CUSTOMER WAS CONCERNED THAT THERE MAY BE DAMAGE TO BOTH THE HEADER AND LEAD. THE LEAD WAS CAPPED AND THE DEVICE WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57242 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R ADDRL1 IMPLANTABLE PULSE GENERATOR