BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2376015 · Received December 15, 2011

    Report

    Report Number
    2649622-2011-18785
    Event Type
    Injury
    Date Received
    December 15, 2011
    Date of Event
    October 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING: 6 - VENTRICULAR NST<=210 MS BETWEEN (B)(6) 2011 18:21:44 AND (B)(6) 2011 07:54:56.

    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. SENSING - OVERSENSING: 6 - VENTRICULAR NST<=210 MS BETWEEN (B)(4) 2011 18:21:44 AND (B)(4) 2011 07:54:56. THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED OVERSENSING, AND THE DEVICE EXHIBITED 2-3 SECOND PAUSES DURING VENTRICULAR PACING. FURTHER REVIEW OF THE DEVICE INFORMATION INDICATED THAT THE PATIENT HAD A RATE OF 30-40 BEATS PER MINUTE FOR A TOTAL OF 20 SECONDS PER DAY. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 6935 IMPLANTABLE TACHY LEAD| 6935 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD