BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 2760762 · Received September 26, 2012

    Report

    Report Number
    2182863-2012-00085
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 25, 2012
    Report Date
    August 30, 2012
    Manufacturer
    SORIN CRM
    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.THE ANALYSIS ON THIS LEAD IS PENDING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS ON THIS LEAD IS PENDING. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE/SYSTEM 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 A LEAD MALFUNCTION IS SUSPECTED ON THIS VENTRICULAR LEAD. ON (B)(6) 2012, SORIN RECOMMENDED THE PHYSICIAN TO EVALUATE THE BENEFIT OF LEAD REPLACEMENT. THE LEAD WAS EXPLANTED ON (B)(6) 2012 AND REPLACED WITH A NEW BIOTRONIK LEAD. NOTE: THE SORIN ICD THAT THIS LEAD ATTACHED TO WAS ALSO REPORTED ON AN MDR.

    Description of Event or Problem · 1

    THE DEVICE/SYSTEM 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 A LEAD MALFUNCTION IS SUSPECTED ON THIS VENTRICULAR LEAD. ON (B)(6) 2012, SORIN RECOMMENDED THE PHYSICIAN TO EVALUATE THE BENEFIT OF LEAD REPLACEMENT. THE LEAD WAS EXPLANTED ON (B)(6), 2012 AND REPLACED WITH A NEW BIOTRONIK LEAD. NOTE: THE SORIN ICD THAT THIS LEAD ATTACHED TO WAS ALSO REPORTED ON AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE LEAD MRM SORIN CRM 2CR-5

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R