BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2130805 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01091
    Event Type
    Injury
    Date Received
    June 16, 2011
    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
    MA, 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) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. IMPEDANCE - VARYING RESISTANCE/IMPEDANCE. WEEKLY PACING IMPEDANCE TREND DATA SHOWS VARYING IMPEDANCE FOR DEFIB AND SVC DEFIB WITH MIN AND MAX SVC DEFIB PACE=52 TO 1072 OHMS RANGE BETWEEN (B)(6) 2010 AND (B)(6) 2011. 13- PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(6) 2010 AND (B)(6) 2011. SENSING - OVERSENSING AND 2 - VENTRICULAR NST<=137 MS AVERAGE V-CYCLE ON (B)(6) 2010 AT 09:09:23 AND 09:14:25. 1 - VF=160 MS AVERAGE V-CYCLE ON (B)(6) 2010 09:13:34.

    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 THE DEVICE WAS EXPLANTED DUE TO A SYSTEM INFECTION. WHEN THE POCKET WAS OPEN FOR THE EXPLANT THE PHYSICIAN NOTED THAT THE RV COIL PIN WAS NOT SECURE IN THE HEADER. THE DEVICE WAS NOT 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 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D164AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R LEAD/(B)(4) IMPLANTABLE PACING LEAD| LEAD/(B)(4) IMPLANTABLE PACING LEAD| LEAD/(B)(4) IMPLANTABLE PACING LEAD