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

Model Number ISOLINE 2CT6

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2020

Event Type  Injury  

Event Description

The subject rv lead was implanted on (b)(6) 2010.In the follow up performed on (b)(6) 2020 no anomaly was identified.On (b)(6) 2020 an inappropriate shock occurred while the patient was cutting his toenail, the physician interrogated the device and confirmed this event.To avoid another inappropriate shock, vf zone continuous cycle was changed from 6 to 20 and the ventricular sensitivity was changed from 0.4mv to 0.8 mv.On (b)(6) 2020 another device check was performed.The ventricular impedance was below 200o while intermittent oversensing was found.Atrial sensitivity, both atrial and ventricular thresholds were normal.No new episode had been recorded since the latest check performed on the previous day.The patient was stable but was hospitalized in order to have inspection for the bloodstream of subclavian vein and superior vena cava.A re-intervention to add a new lead is scheduled on (b)(6) 2020.

Event Description

The subject rv lead was implanted on (b)(6) 2010.In the follow up performed on (b)(6) 2020 no anomaly was identified.On (b)(6) 2020 an inappropriate shock occurred while the patient was cutting his toenail, the physician interrogated the device and confirmed this event.To avoid another inappropriate shock, vf zone continuous cycle was changed from 6 to 20 and the ventricular sensitivity was changed from 0.4mv to 0.8 mv.On (b)(6) 2020 another device check was performed.The ventricular impedance was below 200o while intermittent oversensing was found.Atrial sensitivity, both atrial and ventricular thresholds were normal.No new episode had been recorded since the latest check performed on the previous day.The patient was stable but was hospitalized in order to have inspection for the bloodstream of subclavian vein and superior vena cava.On (b)(6) 2020, a re-intervention was performed.The subject lead was abandoned in the patient's body and another lead was implanted.

Manufacturer Narrative

B5 updated.

Event Description

The subject rv lead was implanted on (b)(6) 2010.In the follow up performed on (b)(6) 2020 no anomaly was identified.On (b)(6) 2020 an inappropriate shock occurred while the patient was cutting his toenail, the physician interrogated the device and confirmed this event.To avoid another inappropriate shock, vf zone continuous cycle was changed from 6 to 20 and the ventricular sensitivity was changed from 0.4mv to 0.8 mv.On (b)(6) 2020 another device check was performed.The ventricular impedance was below 2000 while intermittent oversensing was found.Atrial sensitivity, both atrial and ventricular thresholds were normal.No new episode had been recorded since the latest check performed on the previous day.The patient was stable but was hospitalized in order to have inspection for the bloodstream of subclavian vein and superior vena cava.On (b)(6) 2020 a re-intervention was performed.The subject lead was abandoned in the patient's body and another lead was implanted.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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: 10669631
• MDR Text Key: 211047875
• Report Number: 1000165971-2020-00640
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• 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: 01/11/2021

1 Device was Involved in the Event

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: 07/20/2012
• Device Model Number: ISOLINE 2CT6
• Device Catalogue Number: ISOLINE 2CT6
• Device Lot Number: 2387
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/07/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 12/18/2020
• Supplement Dates FDA Received: 11/13/2020; 01/11/2021
• 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