BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1991627 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02461
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ADDITIONAL FINDINGS OF DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED) AND BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD) AND HELIX MECHANISM. FULL LEAD RETURNED AND ANALYZED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN HOUR POST IMPLANT, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO OVERSENSING. IT WAS NOTED THAT THE LEAD HAD NOISE, AND WHEN THE PHYSICIAN MOVED THE SUTURE SLEEVE, IT PRODUCED SIGNIFICANT OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN HOUR POST IMPLANT, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO OVERSENSING. IT WAS NOTED THAT THE LEAD HAD NOISE, AND WHEN THE PHYSICIAN MOVED THE SUTURE SLEEVE, IT PRODUCED SIGNIFICANT OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER 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 52 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD