BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2811955 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06337
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 2, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. WEEKLY BATTERY VOLTAGE TREND DATA IN SAVE TO DISK FILE (B)(4) SHOWS MIN BAT=2.96 TO 2.64 VOLTS BETWEEN (B)(6) 2012 AND (B)(6)2012 IS BEFORE DEVICE RRT (RECOMMENDED REPLACEMENT TIME) <= 2.62 VOLT.

    Additional Manufacturer Narrative · 1

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

    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. WEEKLY BATTERY VOLTAGE TREND DATA IN SAVE TO DISK FILE (B)(4) SHOWS MIN BAT=2.96 TO 2.64 VOLTS BETWEEN (B)(6) 2012, IS BEFORE DEVICE RRT (RECOMMENDED REPLACEMENT TIME) <(><<)>= 2.62 VOLT. (B)(4) IMPLANTABLE TACHY LEAD (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LONGEVITY WAS LESS THAN EXPECTED FOR PROGRAMMED VALUES COMPARED WITH PUBLISHED SPECIFICATION. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LONGEVITY WAS LESS THAN EXPECTED FOR PROGRAMMED VALUES COMPARED WITH PUBLISHED SPECIFICATION. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LONGEVITY WAS LESS THAN EXPECTED FOR PROGRAMMED VALUES COMPARED WITH PUBLISHED SPECIFICATION. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE PATIENT ALSO REPORTED EXPERIENCING BRUISING AND INTERNAL BLEEDING. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R 4469 COMPETITOR IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD