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); Low impedance (2285)

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

Event Date 02/28/2019

Event Type  Injury  

Event Description

Reportedly, upon interrogation on 28 february 2019, a warning message was displayed, stating that abnormal ventricular lead impedance was measured on (b)(6) 2019.The lead impedance curves showed that low impedance values (below 300 ohms) were recorded since (b)(6) 2019.One episode recorded on (b)(6) 2019 showed ventricular noise oversensing.

Event Description

Reportedly, upon interrogation on (b)(6)2019, a warning message was displayed, stating that abnormal ventricular lead impedance was measured on (b)(6)2019.The lead impedance curves showed that low impedance values (below 300 ohms) were recorded since february 2019.One episode recorded on 27 february 2019 showed ventricular noise oversensing.

• 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: 8443548
• MDR Text Key: 139553747
• Report Number: 1000165971-2019-00151
• 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
• Report Date: 04/23/2019
• 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 Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 04/23/2019
• 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