BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3862548 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06845
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. CONCOMITANT MEDICAL PRODUCTS: 5076-52 IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 2011. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT, THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED LOCAL POCKET STIMULATION WHEN THE RIGHT VENTRICULAR (RV) LEAD OUTPUT WAS INCREASED AND THE LEAD HAD A SUSPECTED FRACTURE. IT WAS NOTED THAT THE PATIENT WAS TAKING PART IN THE SYSTEM LONGEVITY STUDY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POCKET PAIN SYMPTOMS AND THAT THEY WERE CONVINCED IT WAS DUE TO RIGHT VENTRICULAR (RV) LEAD FUNCTION. THE PHYSICIAN DECIDED TO REPLACE THE LEAD AT THE PATIENT'S REQUEST AND TO MOVE THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO A SUB-MUSCULAR LOCATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341134 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R D334DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR