BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN SD

    MDR report key: 2953476 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00332
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 28, 2011
    Report Date
    December 4, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES. (B)(4). THE PHYSICIAN DIDN'T HAVE ANY COMPLAINT WITH THE PRODUCT. CONCOMITANT PRODUCT: 4568 IMPLANTABLE PACING LEAD (B)(6) 2001; 6932 IMPLANTABLE TACHY LEAD (B)(6) 2002.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A POCKET INFECTION. THE DEVICE AND LEAD WERE EXPLANTED AND 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
    56353 ATTAIN SD PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MFG 418985

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR