BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 3051079 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04749
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PRODUCTS: 7961IU IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 1996; 4003 IMPLANTABLE PACING LEAD (B)(6) 1990. (B)(4).

    Additional Manufacturer Narrative · 1

    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 HAD COMPLAINED OF PAIN RELATED TO THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS AND HAD REQUESTED THE LEADS BE REMOVED. THE LEADS WERE INITIALLY INACTIVATED, REPLACED, AND HAVE SINCE BEEN REMOVED. AS A RESULT OF THE PATIENT'S COMPLAINT OF PAIN, THE ENTIRE SYSTEM WAS ALSO MOVED TO THE PATIENT'S OPPOSITE SIDE OF THEIR CHEST. FOLLOW UP RECEIVED INDICATED THERE WERE NO ALLEGATIONS OF A PERFORMANCE ISSUE WITH EITHER LEAD; RATHER THE SURGICAL INTERVENTION WAS A RESULT OF THE PATIENT'S COMPLAINT AND REQUEST. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153766 CAPSURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 450353

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 7071A IMPLANTABLE PULSE GENERATOR (IPG)