MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY SMARTVIEW; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number SMARTVIEW GPRS

Device Problem Power Problem (3010)

Patient Problem No Information (3190)

Event Date 07/04/2019

Event Type  malfunction  

Event Description

Reportedly, the power cable of the subject home monitor is defective.Preliminary analysis confirmed that the power cable was unsoldered.

Event Description

Reportedly, the power cable of the subject home monitor is defective.Preliminary analysis confirmed that the power supply connector was unsoldered.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20191023 - file-2019-02432 - analysis_and_closure_report_resp-2019-01514.Pdf].

• Brand Name: SMARTVIEW
• Type of Device: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 8826277
• MDR Text Key: 152813371
• Report Number: 1000165971-2019-00439
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/04/2019
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1