BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1922820 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13092
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THE LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED. THERE WAS 1 PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2010. THERE WAS ALSO INTERFERENCE/NOISE NOTED. THE VENTRICULAR SHORT INTERVAL COUNT AVG/DAY BETWEEN (B)(6) 2010 WAS 80. OVERSENSING WAS ALSO OBSERVED. THERE WERE 15 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES WITH LESS THAN 210 MS CYCLE LENGTHS BETWEEN (B)(6) 2010 AND 11 VENTRICULAR FIBRILLATION EPISODES WITH LESS THAN 200 MS CYCLE LENGTHS BETWEEN (B)(6) 2010. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    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 THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSING OF ELECTROMAGNETIC INTERFERENCE. IT WAS ALSO REPORTED THAT THERE WAS NO CAPTURE AND DISLODGMENT ON THE RIGHT VENTRICULAR LEAD. THE LEAD REMAINS 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 SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R 4196 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4196 IMPLANTABLE PACING LEAD