MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D

Model Number PLATINIUM CRT-D 1741

Device Problems Telemetry Discrepancy (1629); Reset Problem (3019)

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

Event Date 02/03/2017

Event Type  malfunction  

Event Description

On (b)(6) 2017 during the implant of the subject device, telemetry was lost and was unable to be re-established.Warning messages were displayed indicating the device was in backup mode and required re-initialization either upon attempting to end the programming session or, after ending the session and then re-interrogating the device.Following a delay for re-initialization, successful device testing and dft testing were performed without further incident.Additionally, on (b)(6) 2017, a device follow-up was performed and reports everything seemed to function as expected.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D
• 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): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; 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: 6371411
• MDR Text Key: 69160677
• Report Number: 1000165971-2017-00161
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLATINIUM CRT-D 1741
• Device Catalogue Number: PLATINIUM CRT-D 1741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/03/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1