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

Model Number PLATINIUM VR 1240

Device Problem Wireless Communication Problem (3283)

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

Event Date 02/22/2017

Event Type  malfunction  

Event Description

It was reported that during an implantation procedure, rf communication was lost suddenly.The rf icon at the top of the screen was crossed out and the buttons "interr." and "progr." were grey out.Inductive telemetry also did not work.The interrogation session was ended and the device was interrogated in a new session.The device was re-interrogated in the new session and all parameters were successfully programmed.Preliminary analysis revealed a switch in rms context during rf communication between icd and rf head and programmer.The reason of this switch could not be identified.

Manufacturer Narrative

Preliminary analysis showed that rf issue (unexpected switch in rms context) is due to implant software anomaly.This anomaly will be corrected in next software version.

Event Description

It was reported that during an implantation procedure, rf communication was lost suddenly.The rf icon at the top of the screen was crossed out and the buttons "interr." and "progr." were grey out.Inductive telemetry also did not work.The interrogation session was ended and the device was interrogated in a new session.The device was re-interrogated in the new session and all parameters were successfully programmed.Preliminary analysis revealed a switch in rms context during rf communication between icd and rf head and programmer.The reason of this swich could not be identified.

Manufacturer Narrative

Describe event or problem field corrected (typo).(b)(4).

Event Description

It was reported that during an implantation procedure, rf communication was lost suddenly.The rf icon at the top of the screen was crossed out and the buttons "interr." and "progr." were grey out.Inductive telemetry also did not work.The interrogation session was ended.The device was re-interrogated in the new session and all parameters were successfully programmed.Preliminary analysis revealed a switch in rms context during rf communication between icd and rf head and programmer.The reason of this switch could not be identified.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL (SALUGGIA ITALY); 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6435036
• MDR Text Key: 71206674
• Report Number: 1000165971-2017-00253
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: PLATINIUM VR 1240
• Device Catalogue Number: PLATINIUM VR 1240
• Device Lot Number: S0207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2016
• 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