BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1596030 · Received February 9, 2010

    Report

    Report Number
    2649622-2010-00041
    Event Type
    Injury
    Date Received
    February 9, 2010
    Date of Event
    December 16, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD IS EXHIBITING LOW, FLUCTUATING IMPEDANCES. AT 010510: IT WAS REPORTED THE LEAD WAS REPLACED DUE TO NO CAPTURE AND UNACCEPTABLE THRESHOLDS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD IS EXHIBITING LOW, FLUCTUATING IMPEDANCES. (B)(4): IT WAS REPORTED THE LEAD WAS REPLACED DUE TO NO CAPTURE AND UNACCEPTABLE THRESHOLDS. IT WAS FURTHER REPORTED THAT THE LEAD APPARENTLY FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB