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

Model Number ISOLINE 2CR6

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problem Chest Pain (1776)

Event Date 09/26/2015

Event Type  Injury  

Event Description

The physician reported that during a scheduled follow-up review of the data stored by the associated icd revealed 1 inappropriate shock due to oversensing in the rv channel.Numerous other episodes also showed oversensing relative to the associated channel.A re-intervention is scheduled for (b)(6) 2015 to replace the subject lead.

Manufacturer Narrative

The preliminary analysis identified an insulation breach as the probable cause of the reported electrical issues.

Event Description

The physician reported that during a scheduled follow-up review of the data stored by the associated icd revealed 1 inappropriate shock due to oversensing in the rv channel.Numerous other episodes also showed oversensing relative to the associated channel.A re-intervention is scheduled for (b)(6) 2015 to replace the subject lead.

Manufacturer Narrative

Please refer to the attached investigation report.

Event Description

The physician reported that during a scheduled follow-up review of the data stored by the associated icd revealed 1 inappropriate shock due to oversensing in the rv channel.Numerous other episodes also showed oversensing relative to the associated channel.A re-intervention is scheduled for (b)(6) 2015 to replace the subject lead.

• 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 13040 ; IT 13040
• Manufacturer Contact: david thierman ; via crescentino s.n.; .; saluggia 13040 ; IT 13040 ; 0161487077
• MDR Report Key: 5139862
• MDR Text Key: 27912222
• Report Number: 1000165971-2015-00603
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 10/07/2015

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: 04/21/2011
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/07/2015
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/11/2016; 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: Z-0928-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention