BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 3822691 · Received May 21, 2014

    Report

    Report Number
    1000165971-2014-00287
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 15, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NIK
    PMA / PMN Number
    PP060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT OPERATED AS SPECIFIED.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT RECEIVED AN APPROPRIATE SHOCK ON (B)(6) 2014. SHOCK WAS DELIVERED DUE TO OVERSENSING ON RIGHT VENTRICULAR DEFIBRILLATION LEAD. A REINTERVENTION WAS PERFORMED ON (B)(6) 2014 TO REPLACE THE LEAD; AS THE NEW DEFIBRILLATION LEAD WASN'T THIN ENOUGH TO PASS THROUGH THE VEIN: ACCESS TO THE HEART WAS LIMITED TO A THINNER LEAD. AN IS-1 RIGHT VENTRICULAR LEAD WAS IMPLANTED INTO THE PATIENT TO ASSURE THE SENSING TASK AND NO NEW DEFIBRILLATION LEAD WAS IMPLANTED. AS THE SUBJECT ICD HAS ALMOST ARRIVED AT THE RECOMMENDED REPLACEMENT TIME, IT WAS ALSO REPLACED AND WILL BE RETURNED FOR ANALYSIS. A NEW ICD WAS SUCCESSFULLY IMPLANTED WITH THE NEW IS-1 LEAD FOR SENSING PART; THE IS-1 PART OF THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS CAPPED AND THE RIGHT VENTRICULAR COIL WAS CONNECTED (THE SVC COIL WAS NOT USED ANYMORE). ON (B)(6) 2014, DEFIBRILLATION TEST WAS SUCCESSFULLY DONE: 42J-SHOCK WAS DELIVERED WITH A SHOCK IMPEDANCE OF 69 OHM.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT RECEIVED AN APPROPRIATE SHOCK ON (B)(6) 2014. SHOCK WAS DELIVERED DUE TO OVERSENSING ON RIGHT VENTRICULAR DEFIBRILLATION LEAD. A REINSERTION WAS PERFORMED ON (B)(6) 2014 TO REPLACE THE LEAD; AS THE NEW DEFIBRILLATION LEAD WASN'T THIN ENOUGH TO PASS THROUGH THE VEIN: ACCESS TO THE HEART WAS LIMITED TO A THINNER LEAD. AN IS-1 RIGHT VENTRICULAR LEAD WAS IMPLANTED INTO THE PATIENT TO ASSURE THE SENSING TASK AND NO NEW DEFIBRILLATION LEAD WAS IMPLANTED. AS THE SUBJECT ICD HAS ALMOST ARRIVED AT THE RECOMMENDED REPLACEMENT TIME, IT WAS ALSO REPLACED AND WILL BE RETURNED FOR ANALYSIS. A NEW ICD WAS SUCCESSFULLY IMPLANTED WITH THE NEW IS-1 LEAD FOR SENSING PART; THE IS-1 PART OF THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS CAPPED AND THE RIGHT VENTRICULAR COIL WAS CONNECTED (THE SVC COIL WAS NOT USED ANYMORE). ON (B)(6) 2014, DEFIBRILLATION TEST WAS SUCCESSFULLY DONE: 42J-SHOCK WAS DELIVERED WITH A SHOCK IMPEDANCE OF 69 OHM.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT RECEIVED AN APPROPRIATE SHOCK ON (B)(6) 2014. SHOCK WAS DELIVERED DUE TO OVERSENSING ON RIGHT VENTRICULAR DEFIBRILLATION LEAD. A "REINVERTION" WAS PERFORMED ON (B)(6) 2014 TO REPLACE THE LEAD; AS THE NEW DEFIBRILLATION LEAD WASN¿T THIN ENOUGH TO PASS THROUGH THE VEIN: ACCESS TO THE HEART WAS LIMITED TO A THINNER LEAD. AN IS-1 RIGHT VENTRICULAR LEAD WAS IMPLANTED INTO THE PATIENT TO ASSURE THE SENSING TASK AND NO NEW DEFIBRILLATION LEAD WAS IMPLANTED. AS THE SUBJECT ICD HAS ALMOST ARRIVED AT THE RECOMMENDED REPLACEMENT TIME, IT WAS ALSO REPLACED AND WILL BE RETURNED FOR ANALYSIS. A NEW ICD WAS SUCCESSFULLY IMPLANTED WITH THE NEW IS-1 LEAD FOR SENSING PART; THE IS-1 PART OF THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS CAPPED AND THE RIGHT VENTRICULAR COIL WAS CONNECTED (THE SVC COIL WAS NOT USED ANYMORE). ON (B)(6) 2014, DEFIBRILLATION TEST WAS SUCCESSFULLY DONE: 42J-SHOCK WAS DELIVERED WITH A SHOCK IMPEDANCE OF 69 OHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303649 PARADYM DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D) NIK SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM CRT-D 8750 2448

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention