BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2810818 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16051
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 FULL LEAD WAS RETURNED AND ANALYSIS FOUND THAT THE TURNS IT TOOK TO EXTEND/RETRACT THE HELIX EXCEEDED SPECIFICATIONS. THE TIP ELECTRODE HAD A WHITE SUBSTANCE ON IT, THE WHITE SUBSTANCE WAS IN THE SLEEVE HEAD AND HELIX AND IT APPEARED LIKE CRYSTALLIZED STEROID. THE HELIX/LOBE WAS CANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HELIX OF THE RIGHT VENTRICULAR [RV] LEAD WAS EXTENDED PRIOR TO IMPLANT IN THE PATIENT. HOWEVER, LATER IN THE PROCEDURE, THE HELIX WOULD NOT EXTEND AFTER MULTIPLE ATTEMPTS (TWO SETS OF 25 TURNS). THE PHYSICIAN REQUESTED AND IMPLANTED A DIFFERENT RV LEAD. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other 4568 IMPLANTABLE PACING LEAD