BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1803274 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08817
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    April 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; FULL LEAD WAS RETURNED AND ANALYZED. OUTER TUBING OVERLAY WAS BREACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RV LEAD INTEGRITY WARNING. ADDITIONAL INFORMATION OBTAINED THROUGH FOLLOW UP INDICATE THERE WAS OVERSENSING AND SHORT INTERVAL COUNTS THAT LED TO REPOSITIONING PROCEDURE ON THE DAY AFTER THE IMPLANT. IT WAS FURTHER REPORTED THAT THE PHYSICIAN DISCOVERED A NICK IN THE INSULATION IN THE PROXIMAL PORTION OF THE LEAD POSSIBLY INDICATING DAMAGE AT THE IMPLANT TIME. THE LEAD WAS WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RV LEAD INTEGRITY WARNING. THE LEAD WAS 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD