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

Model Number ISOLINE 2CR6

Device Problems Under-Sensing (1661); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 01/04/2016

Event Type  Injury  

Event Description

During a standard follow-up on (b)(6) 2016, it was verified 3 warning messages: "[3] low shock impedance.Defibrillation system ineffective." "[48] max shock energy ineffective on (b)(6) 2016" "[46] high shock impedance detected on (b)(6) 2016: defibrillation system ineffective." nine shocks were delivered, all of them with stored energy = 41.9j and delivered energy = 0j.The shock lead integrity trend is stable between the expected values.In the memories of the device it was also notified atrial undersensing.The physician changed atrial sensibility from 0.4 mv to 0.2mv.It was scheduled a new follow-up to (b)(6) 2016.

• 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: 5365808
• MDR Text Key: 35920634
• Report Number: 1000165971-2016-00030
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2012
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2427
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/07/2016
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0928-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention