BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 1791380 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03100
    Event Type
    Injury
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    Z-0128-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: (B)(4) A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS FOUND THE CAUSE OF THE HIGH CURRENT DRAIN TO BE CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: (B)(4): A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS FOUND THE CAUSE OF THE HIGH CURRENT DRAIN TO BE CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HE HAS A DEFECTIVE LEAD AND A DEFECTIVE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DETERMINED THAT THE DEVICE WAS EXPLANTED AND REPLACED BECAUSE IT HAD REACHED ERI (ELECTIVE REPLACEMENT INDICATOR), AND THAT THE RIGHT VENTRICULAR LEAD WAS CAPPED PROPHYLACTICALLY. IT WAS ALSO DETERMINED THAT THE PATIENT HAD SOME ISSUES WITH THE INCISION FROM THE SURGERY HEALING PROPERLY, AND THAT THERE WAS NO INFECTION BUT THERE WAS AN ABSCESS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HE HAS A DEFECTIVE LEAD AND A DEFECTIVE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DETERMINED THAT THE DEVICE WAS EXPLANTED AND REPLACED BECAUSE IT HAD REACHED ERI (ELECTIVE REPLACEMENT INDICATOR), AND THAT THE RIGHT VENTRICULAR LEAD WAS CAPPED PROPHYLACTICALLY. IT WAS ALSO DETERMINED THAT THE PATIENT HAD SOME ISSUES WITH THE INCISION FROM THE SURGERY HEALING PROPERLY, AND THAT THERE WAS NO INFECTION BUT THERE WAS AN ABSCESS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A SUSPECTED LEAD FRACTURE ON THE RIGHT VENTRICULAR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD