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 Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  malfunction  

Event Description

When the device was interrogated in rf telemetry, a message appeared saying that the interrogation failed and asking to quit the session to re-interrogate the device.After several attempts, interrogations in rf telemetry were unsuccessful, but regular communication was observed with the cpr3 head.Another device was successfully interrogated in rf, therefore the subject device is incriminated.

Manufacturer Narrative

Preliminary analysis confirmed the reported issue due to a manufacturing issue.

Event Description

When the device was interrogated in rf telemetry, a message appeared saying that the interrogation failed and asking to quit the session to re-interrogate the device.After several attempts, interrogations in rf telemetry were unsuccessful, but regular communication was observed with the cpr3 head.Another device was succesfully interrogated in rf, therefore the subject device is incriminated and was not implanted.

Event Description

When the device was interrogated in rf telemetry, a message appeared saying that the interrogation failed and asking to quit the session to re-interrogate the device.After several attempts, interrogations in rf telemetry were unsuccessful, but regular communication was observed with the cpr3 head.Another device was successfully interrogated in rf, therefore the subject device is incriminated and was not implanted.

Manufacturer Narrative

Please refer to the attached investigation report.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• 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: 7486041
• MDR Text Key: 107455765
• Report Number: 1000165971-2018-00459
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2019
• Device Model Number: PLATINIUM VR 1240
• Device Catalogue Number: PLATINIUM VR 1240
• Device Lot Number: S0276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/05/2018
• Patient Sequence Number: 1