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

Model Number ISOLINE 2CR6

Device Problem Low impedance (2285)

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

Event Date 09/22/2015

Event Type  Injury  

Event Description

Starting from (b)(6) 2015, the icd recorded ventricular fibrillation episodes which were not due to ventricular arrhythmia (without inappropriate therapy).Low impedance measurements were recorded during the last months (rv impedance and svc and rv coil continuities): values < 200 ohm.During the planned patient follow-up ((b)(6) 2015) some artifacts reappeared during the sensing test asking to the patient to move his left arm.The measurements of the impedances gave back <200 ohm, then the rv impedance came back to values like 400 ohm.Since the risk of extracting the subject lead is too high for the patient safety, a new rv lead was implanted to the device on (b)(6) 2015.

Event Description

Since (b)(6) 2015, inappropriate ventricular fibrillation episodes were detected by the device, without inappropriate therapy.Low and abnormal impedance measurements were recorded.During the standard patient follow-up dated (b)(6) 2015, ventricular artifacts were detected during patient movement associated to abnormal lead impedance values.Since the patient risk for extracting the subject lead is too high, a new rv lead was implanted on (b)(6) 2015 and connected to the same device.

• 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: 5161481
• MDR Text Key: 28718558
• Report Number: 1000165971-2015-00622
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physicist
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 09/22/2015

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: 03/06/2009
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/22/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention