BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790006 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14376
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    May 13, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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) PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. SENSING - OVERSENSING: 2 - VENTRICULAR NST=210 MS ON (B)(6) 2012 19:20:45 AND (B)(6) 2012 07:00:18. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED: 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 07:00:20. THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS FOUND ON SEVERAL CONDUCTORS (NOT OBSTRUCTED). THE OUTER TUBING OVERLAY EXHIBITED COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION EXHIBITED A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO OVERSENSING AND NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS LATER REPORTED THAT THE PACE/SENSE PIN WAS FOUND TO BE LOOSE.THE RV LEAD WAS EXPLANTED AND REPLACED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R 5076 IMPLANTABLE PACING LEAD| D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB