BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 2952861 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00250
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE PROGRAMMER PASSED TESTING, WITH NO ANOMALIES FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE PROGRAMMER PASSED TESTING, WITH NO ANOMALIES FOUND. (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 PROGRAMMER SPONTANEOUSLY WENT INTO EMERGENCY VVI PACING MODE DURING LEFT VENTRICULAR (LV) THRESHOLD TEST. THE CLINICIAN REPROGRAMMED THE PATIENT TO THE INITIAL INTERROGATION SETTING AND THEN TRANSFERRED THE PATIENT TO ANOTHER EXAM ROOM TO COMPLETE THE DEVICE CHECK WITH A DIFFERENT PROGRAMMER. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SPONTANEOUSLY WENT INTO EMERGENCY VVI PACING MODE DURING A LEFT VENTRICULAR (LV) THRESHOLD TEST. THE CLINICIAN REPROGRAMMED THE PATIENT TO THE INITIAL INTERROGATION SETTING AND THEN TRANSFERRED THE PATIENT TO ANOTHER EXAM ROOM TO COMPLETE THE DEVICE CHECK WITH A DIFFERENT PROGRAMMER. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SPONTANEOUSLY WENT INTO EMERGENCY VVI PACING MODE DURING LEFT VENTRICULAR (LV) THRESHOLD TEST. THE CLINICIAN REPROGRAMMED THE PATIENT TO THE INITIAL INTERROGATION SETTING AND THEN TRANSFERRED THE PATIENT TO ANOTHER EXAM ROOM TO COMPLETE THE DEVICE CHECK WITH A DIFFERENT PROGRAMMER. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PROGRAMMER HAD BEEN RETURNED FOR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56263 CARELINK PROGRAMMER, PACEMAKER KRG RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD