BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2051629 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05604
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERT IS OBSERVED ON (B)(6) 2011. THIS RISE IS SEEN AS A SPIKE IN THE VPACE IMPEDANCE TO 4047 OHMS ON THE DAILY TRENDS. THE IMPEDANCE FALLS TO 1558 OHMS ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH AND UNSTABLE IMPEDANCE, AND THERE WAS A QUESTION REGARDING FRACTURE. A CHEST X-RAY INDICATED THAT ONE OF THE CONNECTOR PINS OF THE LEAD WAS NOT FULLY SEATED IN THE CONNECTOR. THE PHYSICIAN REOPENED THE POCKET AND RESEATED THE CONNECTOR PINS OF THE LEAD. THE LEAD AND THE DEVICE ARE STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD| 6996 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD