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

Model Number ISOLINE 2CR6

Device Problems Fracture (1260); High impedance (1291); Nonstandard Device (1420); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Information (3190)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

The subject lead was implanted in 2007.However, the month and day of implantation are unknown.An estimated date of implantation is provided in this report as of (b)(6) 2007.

Event Description

Reportedly, there were two inappropriate shocks and impedance increase associated to the subject rv lead.It was suspected lead fracture.The subject lead was abandoned and replaced.

Event Description

Reportedly, there were two inappropriate shocks and impedance increase associated to the subject rv lead.It was suspected lead fracture.The subject lead was abandoned and replaced.

• 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: 9933011
• MDR Text Key: 186725817
• Report Number: 1000165971-2020-00345
• 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
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2010
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2212
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2020
• Event Location: Hospital
• Date Manufacturer Received: 05/13/2020
• 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