BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RING 620RG35 DURAN ANCORE ANNULOPLASTY C

    MDR report key: 2973321 · Received February 21, 2013

    Report

    Report Number
    2025587-2013-00032
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 28, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    KRH
    PMA / PMN Number
    K032810
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN STATES THERE WAS ABSOLUTELY NO ISSUE WITH THE BAND AND THAT THE PATIENT WAS NOT EXPLANTED OR BROUGHT BACK FOR ANYTHING TO DO WITH HIS MITRAL REPAIR. THIS REPORT IS A CORRECTION TO THE INITIAL REPORT, AND THE INITIAL REPORT SHOULD NOT HAVE BEEN SUBMITTED PER THE NEW ADDITIONAL INFORMATION THAT WAS RECEIVED FROM THE PATIENT'S PHYSICIAN. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED IN THE PATIENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. (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

    .

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 11 DAYS POST IMPLANT OF THIS ANNULOPLASTY RING THE PATIENT HAD A REPAIR DONE TO THE RING. NO OTHER DETAILS WERE GIVEN BY THE PATIENT. THE PATIENT REPORTED THAT THEY ARE CURRENTLY DOING WELL, RECOVERING FROM RECENT SURGERY AND HAVE HAD NO ADDITIONAL MEDICAL CONCERNS OR SYMPTOMS TO REPORT AT THIS TIME. THE PATIENT REQUESTED A LIST OF DAILY LIVING ACTIVITIES INFORMATION FOR POST SURGERY AND BROCHURE INFORMATION ON THEIR CURRENT IMPLANTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76382 RING 620RG35 DURAN ANCORE ANNULOPLASTY C RING, ANNULOPLASTY KRH HEART VALVES SANTA ANA 620BG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention