BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2203792 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01324
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. IT WAS NOTED THAT THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUB THRESHOLD LEAD IMPEDANCE ON (B)(6) 2011. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MINIMUM AND MAXIMUM LEFT VENTRICULAR PERMANENT PACE IMPEDANCE FROM 380 TO 4047 OHMS, PEAKING BETWEEN (B)(6) 2011, THEN RETURNING TO A BASELINE OF 323 OHMS ON (B)(6) 2011.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THERE IS A LOOSE LEAD IN THE VENTRICLE. THE PATIENT ALERT WAS TRIGGERED AND THE ALERT WAS TURNED OFF BY THE DOCTOR. FOLLOW UP INDICATED THAT THE PATIENT'S EPICARDIAL LEAD HAS NO CAPTURE AT MAX OUTPUTS. THE LEAD REMAINS IN USE AND A REVISION WILL BE PLANNED AT A LATER DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THERE IS A LOOSE LEAD IN THE VENTRICLE. THE PATIENT ALERT WAS TRIGGERED AND THE ALERT WAS TURNED OFF BY THE DOCTOR. FOLLOW UP INDICATED THAT THE PATIENT'S EPICARDIAL LEAD HAS NO CAPTURE AT MAX OUTPUTS. THE LEAD REMAINS IN USE AND A REVISION WILL BE PLANNED AT A LATER DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER INFORMATION INDICATED THAT THE LEAD WAS CAPPED AND REPLACED. TREND DATA ALSO REVEALED THE IMPEDANCE ON THE LEAD HAD SPIKED TO A HIGH MEASUREMENT PRIOR TO REPLACEMENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THERE IS A LOOSE LEAD IN THE VENTRICLE. THE PATIENT ALERT WAS TRIGGERED AND THE ALERT WAS TURNED OFF BY THE DOCTOR. FOLLOW UP INDICATED THAT THE PATIENT'S EPICARDIAL LEAD HAS NO CAPTURE AT MAX OUTPUTS. THE LEAD REMAINS IN USE AND A REVISION WILL BE PLANNED AT A LATER DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER INFORMATION INDICATED THAT THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O| R D284TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 1999 COMPETITOR IMPLANTABLE PACING LEAD| D284TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| D284TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 1999 COMPETITOR IMPLANTABLE PACING LEAD| 1999 COMPETITOR IMPLANTABLE PACING LEAD