BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK SYSTEM

    MDR report key: 3051557 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01062
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    February 5, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWS
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 MEDICAL PRODUCTS: 5554, IMPLANTABLE PACING LEAD: (B)(6) 2006. 5054, IMPLANTABLE PACING LEAD: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO INCIDENTS OF PASSING OUT. THE PATIENT ADVOCATE REPORTED SIMILAR SYMPTOMS HAD BEEN RECURRING SINCE (B)(4) AND REPORTED THE LEADS WERE "BAD". THE PATIENT AND FAMILY ALSO DISCUSSED WITH A PHYSICIAN WHY THE ISSUES BEING EXPERIENCED BY THE PATIENT DID NOT SHOW UP ON THE CARELINK CHECKS. IT WAS FURTHER REPORTED THAT AFTER THE PATIENT HAD EXPERIENCED THE EPISODE OF SYNCOPE THE THRESHOLDS WERE CHECKED. A PERIOD OF NO-CAPTURE WAS NOTED. IT SEEMED BOTH THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIUM (RA) LEADS WERE HAVING INTERMITTENT ISSUES THAT WERE ONLY HAPPENING DURING THE DAY WHEN THE PATIENT WAS ACTIVE AND MOVING. ALSO, THE PATIENT MAY HAVE BEEN EXPERIENCING SOME ATRIAL FIBRILLATION. IT WAS RECOMMENDED THE PATIENT GO TO THE EMERGENCY ROOM. THE PATIENT DID NOT HAVE A LANDLINE AND THE PATIENT WENT TO A RELATIVE'S HOUSE FOR CARELINK TRANSMISSION. IT WAS NOTED THE CARELINK TRANSMISSIONS WERE SENT OUT IN THE EVENINGS WHEN THE PATIENT WAS AT REST AND EVERYTHING WAS CAPTURING SATISFACTORILY AND THRESHOLDS LOOKED GOOD. THE LEADS WERE CAPPED AND REPLACED. THE CARELINK MONITOR IS BEING 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
    152933 CARELINK SYSTEM DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS RICE CREEK MFG CARELINK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R E2DR01AA, IMPLANTABLE PULSE GENERATOR