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

Model Number ISOLINE 2CT6

Device Problems Defibrillation/Stimulation Problem (1573); Low impedance (2285)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2014

Event Type  Injury  

Event Description

During the follow-up of (b)(6) 2014, two warning messages were displayed: one referring to low shock impedance on (b)(6) 2014; the other one referring to maximum energy shock ineffective on (b)(6) 2014.

Event Description

During the follow-up of (b)(6) 2014, two warning messages were displayed: one referring to low shock impedance on (b)(6) 2014; the other one referring to maximum energy shock ineffective on (b)(6) 2014.

Event Description

During the follow-up of (b)(6) 2014, two warning messages were displayed: one referring to low shock impedance on (b)(6) 2014; the other one referring to maximum energy shock ineffective on (b)(6) 2014.

Manufacturer Narrative

It was reported that on (b)(6) 2015 a re-intervention was performed to correct the issue.Specifically, it was indicated that the subject lead was abandoned and a replacement lead was implanted.

• 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
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; via crescentino s.n.; .; saluggia 1304 0; IT 13040
• Manufacturer Contact: david thierman ; via crescentino s.n.; .; saluggia 13040 ; IT 13040 ; 0161487077
• MDR Report Key: 4283676
• MDR Text Key: 5197990
• Report Number: 1000165971-2014-00664
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2014

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: 12/14/2012
• Device Model Number: ISOLINE 2CT6
• Device Catalogue Number: ISOLINE 2CT6
• Device Lot Number: 2413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/17/2014
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 11/28/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2014; 03/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0928-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention