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 Information (3190)

Event Date 03/05/2015

Event Type  Injury  

Event Description

The physician reported that during a follow-up visit relative to the implanted icd system, the rv coil continuity was less than 200ohms and the svc coil continuity was 215ohms.It was indicated that there was also fluctuating and low ventricular lead impedance since around (b)(6) 2015.Furthermore, a stored episode, dated (b)(6) 2015, showed noise that was not inappropriately treated with shock therapy.An additional follow-up is scheduled for 16 mar 2015 to perform echocardiography and x-ray examinations to exclude the possibility of a cardiac perforation.A re-intervention is scheduled for (b)(6) 2015.A preliminary investigation of the available patient files confirmed: fluctuations in the ventricular pacing impedance trend that started at the end of february; and oversensing in the recorded episodes dated (b)(6) 2015 that were characteristics of a potential lead issue.Recommendations in accordance with the isoline recall (issued in january 2013) have been provided.

Event Description

The physician reported that during a follow-up visit relative to the implanted icd system, the rv coil continuity was less than 200ohms and the svc coil continuity was 215ohms.It was indicated that there was also fluctuating and low ventricular lead impedance since around (b)(6) 2015.Furthermore, a stored episode, dated (b)(6) 2015, showed noise that was not inappropriately treated with shock therapy.An additional follow-up is scheduled for (b)(6) 2015 to perform echocardiography and x-ray examinations to exclude the possibility of a cardiac perforation.A re-intervention is scheduled for (b)(6) 2015.A preliminary investigation of the available patient files confirmed: fluctuations in the ventricular pacing impedance trend that started at the end of (b)(6); and oversensing in the recorded episodes dated (b)(6) 2015 that were characteristics of a potential lead issue.Recommendations in accordance with the isoline recall (issued in (b)(6) 2013) have been provided.

• 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: 4615636
• MDR Text Key: 5701866
• Report Number: 1000165971-2015-00151
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/06/2015

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: Physician
• Device Expiration Date: 01/12/2014
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/06/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 03/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2011
• 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