MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number ISOLINE 2CR6

Device Problems Nonstandard Device (1420); Over-Sensing (1438); Pacing Intermittently (1443); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problem No Information (3190)

Event Date 03/07/2019

Event Type  Injury  

Event Description

Reportedly, ventricular noise oversensing, ventricular pacing inhibition, delivery of inappropriate therapy, intermittent low ventricular lead impedance and rv and svc coils continuity trends were observed for the subject ventricular lead, which was impacted by the field safety notice issued in january 2013 on isoline leads.The defibrillation system should be replaced as the associated icd reached its recommended replacement time.Defibrillation system replacement is being assessed by the physician as defibrillation therapy might no longer be required by the patient.Preliminary analysis revealed that a ventricular lead issue is suspected.

Manufacturer Narrative

Reportedly, a re-intervention was performed to replace the associated icd and atrial lead.

Event Description

Reportedly, ventricular noise oversensing, ventricular pacing inhibition, delivery of inappropriate therapy, intermittent low ventricular lead impedance and rv and svc coils continuity trends were observed for the subject ventricular lead, which was impacted by the field safety notice issued in january 2013 on isoline leads.The defibrillation system should be replaced as the associated icd reached its recommended replacement time.Defibrillation system replacement is being assessed by the physician as defibrillation therapy might no longer be required by the patient.Preliminary analysis revealed that a ventricular lead issue is suspected.

Event Description

Reportedly, ventricular noise oversensing, ventricular pacing inhibition, delivery of inappropriate therapy, intermittent low ventricular lead impedance and rv and svc coils continuity trends were observed for the subject ventricular lead, which was impacted by the field safety notice issued in january 2013 on isoline leads.The defibrillation system should be replaced as the associated icd reached its recommended replacement time.Defibrillation system replacement is being assessed by the physician as defibrillation therapy might no longer be required by the patient.Preliminary analysis revealed that a ventricular lead issue is suspected.

• Brand Name: ISOLINE
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; .; saluggia 13040 ; IT 13040
• MDR Report Key: 8459895
• MDR Text Key: 140202667
• Report Number: 1000165971-2019-00172
• Device Sequence Number: 0
• Product Code: MRM
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2013
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2446
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/07/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 03/29/2019; 05/20/2019
• Supplement Dates FDA Received: 04/26/2019; 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0928-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention