BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2810548 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03718
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 20, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT FOR OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS BROUGHT IN TO DO TESTING WITH THE POCKET OPEN TO CHECK FOR LEAD INTEGRITY. IT WAS ALSO REPORTED THAT THERE WAS POSSIBLY NOISE ON BOTH DEVICE ATRIAL AND VENTRICULAR CHANNELS. AFTER DEVICE REPLACEMENT, NOISE WAS SEEN ON BOTH THE RV AND ATRIAL LEADS, BUT WAS NOT REPRODUCIBLE USING THE ANALYZER. IT WAS THOUGHT THAT THERE MIGHT BE ISSUES AT THE PIN CONNECTION. THE NEW DEVICE WAS TURNED OFF UNTIL THE LEAD REVISION SCHEDULED FOR TWO DAYS LATER. IT WAS THEN REPORTED THAT AT THE LEAD REVISION, NOISE COULD NOT BE REPRODUCED WITH DEVICE MANIPULATION. THE LEADS REMAIN IN USE AND PATIENT WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN 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, INC. 6943

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD