BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 2760750 · Received September 26, 2012

    Report

    Report Number
    2182863-2012-00084
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 25, 2012
    Report Date
    August 30, 2012
    Manufacturer
    SORIN CRM S.A.S.
    Product Code
    MRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012. A FINAL RESPONSE IS PENDING. EVAL SUMMARY: ICD REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4) 2012 - A FINAL RESPONSE IS PENDING. (B)(4) 2012 - SINCE THE DEVICE REMAINS IMPLANTED, THE FILES FROM THE PROGRAMMER WERE REVIEWED. THE FILES REVEALED OVERSENSING EPISODES WHICH DID NOT CORRESPOND TO PHYSIOLOGICAL SIGNALS. THIS PHENOMENON WAS RELATED TO A LEAD ISSUE (DISLODGEMENT, INSULATION FAILURE, CONDUCTOR FAILURE) OR/AND A CONNECTION ISSUE ON THE VENTRICULAR CHANNEL. THE SORIN ISOLINE LEAD (ALSO REPORTED ON AN MDR) WAS REPLACED ON (B)(6) 2012. THIS ICD REMAINS IMPLANTED. USUAL FOLLOW-UP INTERVALS APPLY.

    Description of Event or Problem · 1

    THE DEVICE WAS INTERROGATED AND IT WAS FOUND THAT THE PATIENT HAD RECEIVED 18 SHOCKS. IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT STARTED HAVING NOISE OVERSENSING. THE FILES FROM THE PROGRAMMER WERE SENT TO THE MANUFACTURER FOR A RECOMMENDATION. A PRELIMINARY ANALYSIS SHOWED NUMEROUS EPISODES RECORDED FROM (B)(6) 2012, RELATED TO NOISE DETECTION. EXPERTISE FILES SHOWED THAT THE LEAD MALFUNCTION IS SUSPECTED ON THE VENTRICULAR LEAD. ON (B)(6) 2012, SORIN RECOMMENDED THE PHYSICIAN TO EVALUATE THE BENEFIT OF LEAD REPLACEMENT. THE VENTRICULAR SORIN ISOLINE LEAD WAS EXPLANTED ON (B)(6) 2012 AND THIS ICD REMAINS IMPLANTED WITH A NEW BIOTRONIK LEAD. NOTE: THE SORIN ISOLINE LEAD WAS ALSO REPORTED ON AN MDR.

    Description of Event or Problem · 1

    THE DEVICE WAS INTERROGATED AND IT WAS FOUND THAT THE PATIENT HAD RECEIVED 18 SHOCKS. IT WAS REPORTED THAT ON (B)(6), 2012, THE PATIENT STARTED HAVING NOISE OVERSENSING. THE FILES FROM THE PROGRAMMER WERE SENT TO THE MANUFACTURER FOR A RECOMMENDATION. A PRELIMINARY ANALYSIS SHOWED NUMEROUS EPISODES RECORDED FROM (B)(6), 2012 RELATED TO NOISE DETECTION. EXPERTISE FILES SHOWED THAT THE LEAD MALFUNCTION IS SUSPECTED ON THE VENTRICULAR LEAD. ON (B)(6), 2012, SORIN RECOMMENDED THE PHYSICIAN TO EVALUATE THE BENEFIT OF LEAD REPLACEMENT. THE VENTRICULAR SORIN ISOLINE LEAD WAS EXPLANTED ON (B)(6) 2012 AND THIS ICD REMAINS IMPLANTED WITH A NEW BIOTRONIK LEAD. NOTE: THE SORIN ISOLINE LEAD WAS ALSO REPORTED ON AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MRM SORIN CRM S.A.S. 6550

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R