BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 1860955 · Received October 7, 2010

    Report

    Report Number
    6000094-2010-01945
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    June 11, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS ICD MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; GROMMET DAMAGE WAS OBSERVED AND BLOOD FOUND INSIDE THE RV PORT; DISTAL AND PROXIMAL CONDUCTORS FOUND DISTORTED AND BLOOD PRESENT ON DISTAL CONDUCTOR AND IN/ON THE HELIX MECHANISM, DAMAGED AT IMPLANT; FULL LEAD ANALYZED; DEFIB CONDUCTOR DISTORTED AND BLOOD/BODY FLUID PRESENT ON THE DISTAL CONDUCTOR, APPARENT EXPLANT DAMAGE; THERE ARE TWO SETS OF SETSCREW MARKS ON THE IS-1 PIN AND ONE SET IS TOO PROXIMAL AND ONE SET IS IN THE CORRECT POSITION WHICH INDICATES THAT AT SOME TIME THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE; FULL LEAD ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS ICD MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; GROMMET DAMAGE WAS OBSERVED AND BLOOD FOUND INSIDE THE RV PORT; (B)(4) NO ANOMALIES FOUND; DISTAL AND PROXIMAL CONDUCTORS FOUND DISTORTED AND BLOOD PRESENT ON DISTAL CONDUCTOR AND IN/ON THE HELIX MECHANISM, DAMAGED AT IMPLANT; FULL LEAD ANALYZED; (B)(4) NO ANOMALIES FOUND; DEFIB CONDUCTOR DISTORTED AND BLOOD/BODY FLUID PRESENT ON THE DISTAL CONDUCTOR, APPARENT EXPLANT DAMAGE; THERE ARE TWO SETS OF SETSCREW MARKS ON THE IS-1 PIN AND ONE SET IS TOO PROXIMAL AND ONE SET IS IN THE CORRECT POSITION WHICH INDICATES THAT AT SOME TIME THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE; FULL LEAD ANALYZED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT OF THE SYSTEM, ALL MEASUREMENTS WERE NORMAL. DURING AN EVALUATION A FEW DAYS LATER THE FOLLOWING MEASURES WERE NOTED: PACING THRESHOLD = 8 V, PULSE WIDTH = 1.5 MS AND LEAD IMPEDANCE = > 2000 OHMS. A SURGICAL VERIFICATION WAS MADE AND DURING THE PROCEDURE THE VENTRICLE CONNECTION CHANNEL WAS FOUND FULL OF BLOOD. THE LEAD WAS REPOSITIONED AND THE CONNECTOR AND THE LEAD WERE CLEANED. THE PACING MEASUREMENTS WERE NORMAL BUT BLOOD AT THE CONNECTOR WAS OBSERVED. THE SYSTEM WAS EXPLANTED. DURING THE SYSTEM RE-IMPLANT DONE AT A LATER DATE, A LEAD WAS REPOSITIONED MULTIPLE TIMES BUT ALL SHOWED PACING THRESHOLDS MORE THAN 2 V AND HIGH IMPEDANCE. A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D164VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R