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

Model Number ISOLINE 2CR6

Device Problems Intermittent Capture (1080); Over-Sensing (1438); Low impedance (2285); Decreased Sensitivity (2534)

Patient Problem No Information (3190)

Event Date 02/04/2020

Event Type  Injury  

Event Description

The subject defibrillation lead was implanted on (b)(6) 2009 and connected to a replacement icd on 13 april 2016.Reportedly, during a follow-up performed on (b)(6) 2020, an issue at the level of the defibrillation lead, with low detection and sensitivity, was observed.Since a lead issue was suspected, a re-intervention was performed the next day.The defibrillation lead was abandoned in the patient¿s body and a new one was implanted.Based on preliminary analysis, a defibrillation lead issue is suspected.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

The subject defibrillation lead was implanted on (b)(6) 2009 and connected to a replacement icd on (b)(6) 2016.Reportedly, during a follow-up performed on (b)(6) 2020, an issue at the level of the defibrillation lead, with low detection and sensitivity, was observed.Since a lead issue was suspected, a re-intervention was performed the next day.The defibrillation lead was abandoned in the patient¿s body and a new one was implanted.Based on preliminary analysis, a defibrillation 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: 9756498
• MDR Text Key: 181541639
• Report Number: 1000165971-2020-00277
• 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: 04/16/2020

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 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/04/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/16/2020
• 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