BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 2368623 · Received December 12, 2011

    Report

    Report Number
    2649622-2011-17396
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 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. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED: 2 - PATIENT ALERTS FOR LEAD FAILURE PREDICTOR ON (B)(4) 2011 21:00:04 AND (B)(4) 2011 16:00:03. SENSING - OVERSENSING: 13 - VENTRICULAR NST<=210 MS BETWEEN (B)(4) 2011 16:20:03 AND (B)(4) 2011 14:20:02. SENSING - INTERFERENCE/NOISE: VENTRICULAR SHORT INTERVAL COUNT V-SIC=33.6 COUNTS AVG/DAY, IN 7.15 DAYS, BETWEEN (B)(4) 2011 13:38:02 AND (B)(4) 2011 17:17:03.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH THE PATIENT ALERT AND THE LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO OVERSENSING. THE PATIENT WAS NOTED TO HAVE A RECENT ONSET OF ATRIAL FIBRILLATION. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other 4196 IMPLANTABLE PACING LEAD| 5068 X2 IMPLANTABLE PACING LEADS| 8042 IMPLANTABLE PULSE GENERATOR| 8042 IMPLANTABLE PULSE GENERATOR| 4196 IMPLANTABLE PACING LEAD| D274VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5068 X2 IMPLANTABLE PACING LEADS| D274VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB