BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2133986 · Received June 20, 2011

    Report

    Report Number
    2649622-2011-09980
    Event Type
    Injury
    Date Received
    June 20, 2011
    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
    FL, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO AN APPARENT FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD WITH HIGH IMPEDANCE AND OVERSENSING NOTED. THE LEAD WAS EXPLANTED AND A NEW RV LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO AN APPARENT FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD WITH HIGH IMPEDANCE AND OVERSENSING NOTED. THE PATIENT ALSO HAD ANOTHER RIGHT VENTRICULAR LEAD THAT HAD PREVIOUSLY BEEN CAPPED DUE TO AN APPARENT FRACTURE WHICH RESULTED IN INAPPROPRIATE SHOCKS. BOTH OF THE LEADS WERE EXPLANTED AND A NEW RV LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO AN APPARENT FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPLANTED AND A NEW RV LEAD WAS IMPLANTED. 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 64 YR Hospitalization| L| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD