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

Model Number ISOLINE 2CR5

Device Problem Low impedance (2285)

Patient Problem Ventricular Tachycardia (2132)

Event Date 06/18/2019

Event Type  Injury  

Event Description

Summary: ventricular noise oversensing, low impedance in icd lead, rv coil, and svc coil after defibrillation shocks.On (b)(6) 2019, the patient visited the hospital¿s emergency unit due to icd shock delivery during sleep.As ventricular tachycardia (vt) was still observed after icd shock, an external defibrillator was used at the hospital.Defibrillator pads were put on normal positions and shocks were delivered at 100j, 150j, 200j and 220j, but vt was still observed.The patient was fully conscious and the physician was called for instruction.The physician confirmed that the icd was implanted in the right pectoral position and the defibrillator pads were put just above the icd.The physician immediately repositioned the pads on the back and the forth of the patient¿s body.Drug was given to the patient and external defibrillation was again performed at 270j for 3 to 4 times, and vt was confirmed to stop.Icd check was performed just after the defibrillation and values were confirmed normal.Measurement was again performed later and low impedance below 200 ohms was confirmed in icd lead, rv coil and svc coil.Ventricular pacing threshold was confirmed to have slightly elevated.Noise oversensing on the ventricular chamber due to icd lead fracture was observed while true vt was also confirmed.On (b)(6) 2019, icd check was periodically performed since the event occurred.Impedances and coil continuity measurements were unstable with abnormal values below 200ohms but also normal values.Pacing failure was observed at 6.0v/1.0ms.The icd was reprogrammed to safer mode and shock therapy was turned off.Follow-up on the patient was continued.On (b)(6) 2019, a re-intervention was performed.All systems as well as an abandoned ventricular lead, which had been implanted on (b)(6) 2009 were removed from the patient¿s body.The subject icd lead was not measured with a psa during the re-intervention.A new crt-d was implanted in the left pectoral position and the re-intervention was finished.

Event Description

Summary: ventricular noise oversensing, low impedance in icd lead, rv coil, and svc coil after defibrillation shocks on (b)(6)2019 , the patient visited the hospital¿s emergency unit due to icd shock delivery during sleep.As ventricular tachycardia (vt) was still observed after icd shock, an external defibrillator was used at the hospital.Defibrillator pads were put on normal positions and shocks were delivered at 100j, 150j, 200j and 220j, but vt was still observed.The patient was fully conscious and the physician was called for instruction.The physician confirmed that the icd was implanted in the right pectoral position and the defibrillator pads were put just above the icd.The physician immediately repositioned the pads on the back and the forth of the patient¿s body.Drug was given to the patient and external defibrillation was again performed at 270j for 3 to 4 times, and vt was confirmed to stop.Icd check was performed just after the defibrillation and values were confirmed normal.Measurement was again performed later and low impedance below 200 ohms was confirmed in icd lead, rv coil and svc coil.Ventricular pacing threshold was confirmed to have slightly elevated.Noise oversensing on the ventricular chamber due to icd lead fracture was observed while true vt was also confirmed.On (b)(6)2019 , icd check was periodically performed since the event occurred.Impedances and coil continuity measurements were unstable with abnormal values below 200ohms but also normal values.Pacing failure was observed at 6.0v/1.0ms.The icd was reprogrammed to safer mode and shock therapy was turned off.Follow-up on the patient was continued.On (b)(6)2019 , a re-intervention was performed.All systems as well as an abandoned ventricular lead, which had been implanted on (b)(6)2009 were removed from the patient¿s body.The subject icd lead was not measured with a psa during the re-intervention.A new crt-d was implanted in the left pectoral position and the re-intervention was finished.

Manufacturer Narrative

The preliminary analysis suggests that the reported event is due to an issue with the subject lead.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Summary: ventricular noise oversensing, low impedance in icd lead, rv coil, and svc coil after defibrillation shocks on (b)(6)2019 , the patient visited the hospital¿s emergency unit due to icd shock delivery during sleep.As ventricular tachycardia (vt) was still observed after icd shock, an external defibrillator was used at the hospital.Defibrillator pads were put on normal positions and shocks were delivered at 100j, 150j, 200j and 220j, but vt was still observed.The patient was fully conscious and the physician was called for instruction.The physician confirmed that the icd was implanted in the right pectoral position and the defibrillator pads were put just above the icd.The physician immediately repositioned the pads on the back and the forth of the patient¿s body.Drug was given to the patient and external defibrillation was again performed at 270j for 3 to 4 times, and vt was confirmed to stop.Icd check was performed just after the defibrillation and values were confirmed normal.Measurement was again performed later and low impedance below 200 ohms was confirmed in icd lead, rv coil and svc coil.Ventricular pacing threshold was confirmed to have slightly elevated.Noise oversensing on the ventricular chamber due to icd lead fracture was observed while true vt was also confirmed.On (b)(6)2019 , icd check was periodically performed since the event occurred.Impedances and coil continuity measurements were unstable with abnormal values below 200ohms but also normal values.Pacing failure was observed at 6.0v/1.0ms.The icd was reprogrammed to safer mode and shock therapy was turned off.Follow-up on the patient was continued.On (b)(6)2019 , a re-intervention was performed.All systems as well as an abandoned ventricular lead, which had been implanted on (b)(6)2009 were removed from the patient¿s body.The subject icd lead was not measured with a psa during the re-intervention.A new crt-d was implanted in the left pectoral position and the re-intervention was finished.

• 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: 8812226
• MDR Text Key: 151759849
• Report Number: 1000165971-2019-00423
• 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: 10/01/2019

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 Model Number: ISOLINE 2CR5
• Device Catalogue Number: ISOLINE 2CR5
• Device Lot Number: 2278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2019
• Event Location: Home
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 07/24/2019; 09/09/2019
• Supplement Dates FDA Received: 08/14/2019; 10/01/2019
• 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