BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1862837 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10513
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: FACILITY INFORMATION. EVENT DESCRIPTION. DEVICE CODES. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS CONCLUDED THAT THERE IS HIGH AND VARYING RESISTANCE/IMPEDANCE. SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERTS ARE OBSERVED ON (B)(4) 2010 AND THE PACING LEAD IMPEDANCE TRENDS CONFIRM SPIKES IN MAXIMUM LEFT VENTRICULAR PERMANENT PACING IMPEDANCE TRENDS ON THE DATES OF THE NOTED PATIENT ALERTS AT IMPEDANCES AS HIGH AS 4047 OHMS. MINIMUM IMPEDANCES ARE AS LOW AS 551 OHMS. (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA (B)(4) COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. (B)(4) IMPEDANCE - HIGH RESISTANCE/IMPEDANCE (B)(4) OOT SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERTS ARE OBSERVED ON (B)(6) 2010. (B)(4) IMPEDANCE - VARYING RESISTANCE/IMPEDANCE (B)(4) PACE LEAD IMPEDANCE TRENDS CONFIRM SPIKES IN MAX LV PERM PACE IMPEDANCE TRENDS ON DATES OF NOTED PATIENT ALERTS AT IMPEDANCES AS HIGH AS 4047 OHMS. MIN IMPEDANCES ARE AS LOW AS 551 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT FOR HIGH LEFT VENTRICULAR (LV) IMPEDANCE WAS SEEN IN THE OBSERVATION SCREEN. THE POLARITY FOR THE LEAD WAS REPROGRAMMED WITH THE DEVICE. AT A LATER DATE THE PATIENT CAME IN BECAUSE THE PATIENT WAS NOT FEELING WELL. A HIGH IMPEDANCE WAS NOTED AGAIN. THE LEAD WAS PROGRAMMED OFF AT THAT TIME. THE PATIENT WAS SEEN AGAIN TO CHECK THE LEAD AND QUESTIONED IF THERE WAS A LEAD FRACTURE PRESENT. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH LV IMPEDANCE ALERT WAS SEEN IN THE OBSERVATION SCREEN. A POSSIBLE CONNECTION ISSUE WITH THE LV TIP WAS NOTED. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY ASKU OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD