BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 1951671 · Received January 6, 2011

    Report

    Report Number
    2647346-2011-00009
    Event Type
    Injury
    Date Received
    January 6, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING 3 - VENTRICULAR NST<=170 MS AVERAGE V-CYCLE ON (B)(6) 2010 IN THE TIMEFRAME BETWEEN 17:33:40 AND 17:33:47. BATTERY VOLTAGE - PRE/APPROACHING ER LAST BATTERY MEASUREMENT=2.65 VOLT ON (B)(6) 2010 IS JUST BEFORE ERI <= 2.62 VOLT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD LOW BATTERY VOLTAGE AND SHOWED T-WAVE OVERSENSING. THE DEVICE WAS REPROGRAMMED DUE TO THE T-WAVE OVERSENSING AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD LOW BATTERY VOLTAGE AND SHOWED T-WAVE OVERSENSING. THE DEVICE WAS REPROGRAMMED DUE TO THE T-WAVE OVERSENSING AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE HAS REACHED THE ELECTIVE REPLACEMENT INDICATOR, A PATIENT ALERT SOUNDED, AND THERE WAS A PROBLEM WITH THE DEVICE TRANSMITTING DATA. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    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 15 YR Other COMPETITOR IMPLANTABLE TACHY LEAD| COMPETITOR IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD