MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY SMARTVIEW; UNKNOWN

Model Number SMARTVIEW GPRS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  malfunction  

Event Description

It was reported that the hospital received (on (b)(6) 2017) a notification saying that no remote communication has been received since 14 days.However, the patient was implanted on (b)(6) 2017 and received the remote monitoring system on (b)(6) 2017.It was also reported that in the notification it was mentioned that the last device record was dated (b)(6) 2016.Preliminary analysis confirmed that the reported issue is due to a file related to the manufacturing process that has not been erased before the home monitoring delivery.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

It was reported that the hospital received (on (b)(6) 2017) a notification saying that no remote communication has been received since 14 days.However, the patient was implanted on (b)(6) 2017 and received the remote monitoring system on (b)(6) 2017.It was also reported that in the notification it was mentioned that the last device record was dated (b)(6) 2016.Preliminary analysis confirmed that the reported issue is due to a file related to the manufacturing process that has not been erased before the home monitoring delivery.

• Brand Name: SMARTVIEW
• Type of Device: UNKNOWN
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): EOLANE BLD J. BAPTISTE COLBERT 49520 COMBREE FRANCE; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 7107609
• MDR Text Key: 95179792
• Report Number: 1000165971-2017-00917
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SMARTVIEW GPRS
• Device Catalogue Number: SMARTVIEW GPRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/15/2017
• Event Location: Hospital
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1