BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2131878 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10580
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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.

    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 FOR (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. RESISTANCE/IMPEDANCE INCREASE, WEEKLY PACE MEASUREMENT LOG DATA SHOWS AN INCREASE FOR MIN AND MAX V.PACE EQUAL TO 432 TO 600 OHMS PEAK BETWEEN (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RISE IN RIGHT VENTRICULAR (RV) LEAD IMPEDANCE. IT WAS ALSO REPORTED THAT THERE WAS AN RV LEAD FRACTURED AND HAD HIGH IMPEDANCE. THE DEVICE HAS BEEN TURNED OFF AND THE PATIENT IS WEARING A LIFE VEST BECAUSE THEY HAVE AN INFECTION. ONCE THE INFECTION CLEARS THE RV LEAD WILL BE EXTRACTED AND 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 RISE IN RIGHT VENTRICULAR (RV) LEAD IMPEDANCE. IT WAS ALSO REPORTED THAT THERE WAS AN RV LEAD FRACTURED AND HAD HIGH IMPEDANCE. THE DEVICE HAS BEEN TURNED OFF AND THE PATIENT IS WEARING A LIFE VEST BECAUSE THEY HAVE AN INFECTION, WHICH PER THE PHYSICIAN WAS A "COMPLICATION OF THE PROCEDURE, NOT THE DEVICE." ONCE THE INFECTION CLEARS THE RV LEAD WILL BE EXTRACTED AND REPLACED. IT WAS ALSO REPORTED THAT THE RV LEAD SHOWED OVERSENSING WHICH WAS ATTRIBUTED TO AN APPARENT LEAD FRACTURE. THE LEAD WAS CUT AND REMOVED. 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 RISE IN RIGHT VENTRICULAR LEAD IMPEDANCE. THE LEAD REMAINS IN USE. 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 FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6931 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB