BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2128058 · Received June 15, 2011

    Report

    Report Number
    2649622-2011-09706
    Event Type
    Injury
    Date Received
    June 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    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 DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SAVE TO DISK REVIEW REVEALED THAT THE LEAD INTEGRITY ALERT TRIGGERED. 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2011 16:35:51. OVERSENSING OCCURRED. 6 - VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES OF<=210 MS AVERAGE V-CYCLE OCCURRED BETWEEN (B)(6) 2010 08:27:09 AND (B)(6) 2011 07:56:52. INTERFERENCE/NOISE WAS OBSERVED. VENTRICULAR SHORT INTERVAL COUNT V-SIC=4.1 COUNTS AVG/DAY, IN 11.02 DAYS, BETWEEN (B)(6) 2011 16:59:28 AND (B)(6) 2011 17:28:58.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT TRIGGERED DUE TO OVERSENSING AND NOISE. THERE WAS UNDERSENSING SEEN ON REALTIME ELECTROCARDIOGRAM. THE SENSING WAS PROGRAMMED TO TIP TO COIL. 5 DAYS LATER IT WAS REPORTED THAT NO OVERSENSING WAS SEEN BUT R-WAVES REMAIN LOW. TWO WEEKS LATER IT WAS REPORTED THAT WITH TIP TO COIL SENSING THERE WAS SLIGHT NOISE OBSERVED ON ELECTROCARDIOGRAM. IT WAS ALSO REPORTED THAT IT WAS SUSPECTED THAT WHAT IS OCCURRING MIGHT POINT TO A COIL FRACTURE. THE LEAD REMAINS IN USE. 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 QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD