BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 3992197 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02409
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 419688 LEAD IMPLANTED: 2011-(B)(6); 5867-3M ADAPTOR IMPLANTED: 2014-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY - DEFIBRILLATOR (CRT-D) POCKET WAS REVISED DUE TO A HEMATOMA THAT HAD FOR MED WITHIN THE POCKET. THE PHYSICIAN DID NOT SUSPECT THE POCKET TO BE INFECTED AT THE TIME SO THE DEVICE WAS LEFT IN SERVICE. INFORMATION OBTAINED DURING FOLLOW-UP WITH THE PHYSICIAN THAT HANDLED THE CASE INDICATED THAT AN INFECTION WAS DISCOVERED AT A LATER DATE AND THAT THE SYSTEM WAS EXPLANTED AT ANOTHER HOSPITAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471634 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6725

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R DTBA1D1 ICD