BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLINE

    MDR report key: 2122154 · Received June 13, 2011

    Report

    Report Number
    2182863-2011-00052
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    March 29, 2011
    Report Date
    May 16, 2011
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2011,THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4).CORRECTED INFORMATION WAS RECEIVED ON THIS CASE ON (B)(6), 2012. THE LEAD WAS ACTUALLY IMPLANTED (B)(6), 2011. ON (B)(6), 2011, A RE-INTERVENTION WAS PERFORMED SINCE THE LEAD HAD DISLODGED. DURING THE REPOSITIONING, THE LEAD WAS PERFORATED BY THE STYLET AND WAS EXPLANTED. A NEW BIOTRONIK LEAD WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4) 2011. THE ANALYSIS ON THIS DEVICE IS PENDING.

    Additional Manufacturer Narrative · 1

    (B)(4), 2011.THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4).

    Description of Event or Problem · 1

    AT THE IMPLANTATION PROCEDURE, THE LEAD WAS PERFORATED AT THE RV COIL BY THE STYLET DURING REPOSITIONING. THE LEAD WAS NOT IMPLANTED.

    Description of Event or Problem · 1

    AT THE IMPLANTATION PROCEDURE, THE LEAD WAS PERFORATED AT THE RV COIL BY THE STYLET DURING REPOSITIONING. THE LEAD WAS NOT IMPLANTED.

    Description of Event or Problem · 1

    AT THE IMPLANTATION PROCEDURE, THE LEAD WAS PERFORATED AT THE RV COIL BY THE STYLET DURING REPOSITIONING. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE LEAD MRM SORIN BIOMEDICA CRM S.R.L. 2CR-6

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR