BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 2049289 · Received April 11, 2011

    Report

    Report Number
    2649622-2011-05212
    Event Type
    Injury
    Date Received
    April 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S33
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. FIFTEEN - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=210 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 07:19:47 AND 15:01:57. FOUR - VF (VENTRICULAR FIBRILLATION) <=200 MS BETWEEN (B)(6) 2011 08:19:39 AND (B)(6) 2011 17:41:45. VENTRICULAR SHORT INTERVAL COUNT V-SIC=14.9 COUNTS AVG/DAY, IN 7.99 DAYS, BETWEEN (B)(6) 2011 18:01:33 AND (B)(6) 2011 17:52:35. ONE - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2011 19:44:45.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR SYNCOPE. EVALUATION ON THE LEAD SHOWED MANY NON-SUSTAINED TACHYCARDIA EPISODES AND ONE VENTRICULAR FIBRILLATION EPISODE SHOWING NOISE LEADING TO PACING INHIBITION AND ONE SHOCK. THE LEAD INTEGRITY ALERT TRIGGERED FOR SHORT INTERVAL COUNTS AND NON-SUSTAINED TACHYCARDIA EPISODES. THE LEAD WAS CAPPED AND 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
    1 CAPSURE Z IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5034 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4194 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 5534 IMPLANTABLE PACING LEAD