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 10/19/2015

Event Type  Injury  

Event Description

During a regular follow-up (on (b)(6) 2015), svc coil impedance was shown as below 200 ohm while other values (e.G.Lead impedance, pacing threshold, and amplitude) were normal and some episodes revealed noise oversensing.V lead measurement curve showed that v pacing lead impedance, whose normal value is around 500 ohm, had been intermittently decreased to abnormally low values around 250 ohm.With the aforementioned anomalies, it was considered that the svc coil and v pacing lead could have caused those vf episodes with noise in some way.The lead was replaced on (b)(6) 2015.The re-intervention revealed that the insulation was deformed due to lead fracture.In addition the, this deformed part was observed to be strongly bent into the pocket.Since the rv df-1 coil was too difficult to remove, it was cut off and removed.Other coils were extracted and the distal part of the lead was abandoned and capped.

Event Description

During a regular follow-up (on (b)(6) 2015), svc coil impedance was shown as below 200 ohm while other values (e.G.Lead impedance, pacing threshold, and amplitude) were normal and some episodes revealed noise oversensing.V lead measurement curve showed that v pacing lead impedance, whose normal value is around 500 ohm, had been intermittently decreased to abnormally low value around 250 ohm.With the aforementioned anomalies, it was considered that the svc coil and v pacing lead could have caused those vf episodes with noise in some way.The lead was replaced on (b)(6) 2015.The re-intervention revealed that the insulation was deformed due to lead fracture.In addition the, this deformed part was observed to be strongly bent into the pocket.Since the rv df-1 coil was too difficult to remove, it was cut off and removed.Other coils were extracted and the distal part of the lead was abandoned and capped.

• 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: 5232331
• MDR Text Key: 31462241
• Report Number: 1000165971-2015-00692
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

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: 04/26/2010
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/21/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2008
• 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