BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURESENSE

    MDR report key: 3151535 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05502
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT ID (B)(4), IMPLANTABLE PULSE GENERATOR, IMPLANTED: (B)(6) 2013, (B)(4) IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE MEDICAL FACILITY COMPLAINING OF CHEST PAIN. THRESHOLDS WERE NOTED TO BE ¿MARKEDLY INCR EASED.¿ AN X-RAY AND CT SCAN WERE PERFORMED AND PERFORATION BY THE VENTRICULAR IMPLANTABLE PACING LEAD WAS SUSPECTED. IT WAS ALSO REPORTED THE R-WAVE AMPLITUDE DECLINED BUT THERE WAS NO CHANGE IN IMPEDANCE. THE LEAD WAS EXPLANTED BY "MANUAL TRACTION" AND THE V-PORT ON THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE WAS PLUGGED. THE IPG WAS SET TO AAI MODE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252282 CAPSURESENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407452

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R