BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1923029 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13191
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 ANALYZED AND NO ANOMALIES WERE FOUND. THE HELIX EXTENDS AND RETRACTS WITHIN PRODUCT SPECIFICATION. THE DEFIBRILLATION CONDUCTOR WAS DISTORTED; THE INNER TUBING KINKED/BUCKLED; THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN REPOSITIONING THE LEAD DURING IMPLANT, THE SCREW WOULD NOT DEPLOY. IT WAS ALSO REPORTED THAT THE LEAD WAS TOO BIG FOR THE PATIENTS ANATOMY. THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN REPOSITIONING THE LEAD DURING IMPLANT, THE SCREW WOULD NOT DEPLOY. IT WAS ALSO REPORTED THAT THE LEAD WAS TOO BIG FOR THE PATIENT'S ANATOMY. THE LEAD WAS NOT IMPLANTED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 5076 (X2) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 (X2) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR