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

Model Number ISOLINE 2CR6

Device Problems Nonstandard Device (1420); Failure to Analyze Signal (1539)

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

Event Date 01/04/2018

Event Type  Injury  

Event Description

It was reported that several episodes with ventricular noise oversensing probably related to a lack of lead insulation were observed in the device memory.The internal cardioverter defibrillation (icd) replacement is imminent, the physician would like to know if the ventricular lead must be replaced.Recommendation to replace the ventricular lead were provided on (b)(6) 2018.

Event Description

It was reported that several episodes with ventricular noise oversensing probably related to a lack of lead insulation were observed in the device memory.The internal cardioverter defibrillation (icd) replacement is imminent, the physician would like to know if the ventricular lead must be replaced.Recommendation to replace the ventricular lead were provided on (b)(6) 2018.

• 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: 7230406
• MDR Text Key: 98669836
• Report Number: 1000165971-2018-00124
• Device Sequence Number: 0
• Product Code: MRM
• Reporter Country Code: FR
• PMA/PMN Number: P980049
• 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: 01/04/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2012
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/04/2018
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2009
• 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