BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2952576 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00629
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATION CO., VILLABLA
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE INFORMATION WAS RECEIVED, ANALYZED, AND VARYING RESISTANCE/IMPEDANCE WAS NOTED. THE WEEKLY PACE IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES AS MAXIMUM VENTRICULAR PACE BIPOLAR IMPEDANCE WAS 437 TO 1064 OHMS BETWEEN (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. THE EXPOSED RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH, THE DISTAL END OF THE RV ELECTRODE WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH, THE HELIX OF THE LEAD WAS EXTRINSICALLY COMPRESSED, THE OUTER INSULATION OF THE LEAD DEVELOPED A COSMETIC DEPRESSION WHILE IN VIVO, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE ANALYST ALSO NOTED THAT THE LEAD SEGMENTS THAT WERE RETURNED WERE THOROUGHLY ANALYZED ELECTRICALLY AND VISUALLY (INCLUDING DESTRUCTIVE ANALYSIS) IN AN ATTEMPT TO FIND AN EXPLANATION FOR THE ¿INCREASED AND VARYING IMPEDANCE¿ DESCRIBED IN THE EVENT. RESULTS FOR ALL ELECTRICAL AND VISUAL TESTING WERE WITHIN SPECIFIED PARAMETERS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD INCREASED AND VARYING IMPEDANCE. INITALLY THE SVC COIL WAS PROGRAMMED OFF. LATER 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 THE RIGHT VENTRICULAR LEAD HAD INCREASED AND VARYING IMPEDANCE. INITIALLY THE SVC COIL WAS PROGRAMMED OFF. LATER 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 THE RIGHT VENTRICULAR LEAD HAD INCREASED AND VARYING IMPEDANCE. INITIALLY THE SVC COIL WAS PROGRAMMED OFF. LATER THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56945 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATION CO., VILLABLA 6943

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D234VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC