BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 5027406 · Received August 25, 2015

    Report

    Report Number
    1000165971-2015-00519
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 20, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP980049
    Removal / Correction Number
    Z-0928-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED INVESTIGATION REPORT.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED OVERSENSING WITHIN STORED EPISODE OF THE ASSOCIATED ICD. IT WAS ALSO INDICATED THAT THE LEAD MEASUREMENT SHOWED LOW SENSING (AROUND 4.5 MV). A RE-INTERVENTION WAS PERFORMED TO CORRECT THE ISSUE BY REPLACING THE LEAD, WHICH COULD ONLY BE PARTIALLY EXPLANTED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED OVERSENSING WITHIN STORED EPISODE OF THE ASSOCIATED ICD. IT WAS ALSO INDICATED THAT THE LEAD MEASUREMENT SHOWED LOW SENSING (AROUND 4.5 MV). A RE-INTERVENTION WAS PERFORMED TO CORRECT THE ISSUE BY REPLACING THE LEAD, WHICH COULD ONLY BE PARTIALLY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561068 ISOLINE DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE 2CR6 2400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention