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

Model Number ISOLINE 2CT6

Device Problems Over-Sensing (1438); Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

Please refer to the analysis report.

Event Description

On (b)(6) 2016, during a routine follow-up, a warning related to the right ventricular lead impedance<200ohm was observed.Right ventricular lead impedance test indicated a value of 368ohms, but the impedance trend revealed that right ventricular lead impedance values decreased since the beginning of (b)(6).It has been observed that 52 fv episodes were recorded by the device but 14 episodes were recorded (with egm), they review revealed a breaking shape noise and the signal oversensing.No therapy has been delivered.

• 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: 6000084
• MDR Text Key: 56488041
• Report Number: 1000165971-2016-00612
• 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
• Report Date: 10/03/2016

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: 05/30/2014
• Device Model Number: ISOLINE 2CT6
• Device Catalogue Number: ISOLINE 2CT6
• Device Lot Number: 2533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/03/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2011
• 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