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

Model Number PLATINIUM DR 1540

Device Problem Issue With Displayed Error Message (2967)

Patient Problem No Information (3190)

Event Date 03/03/2017

Event Type  malfunction  

Event Description

Reportedly, the subject icd was interrogated during a standard follow-up some days after implantation.At interrogation, the device showed many unexpected and unjustified warnings with impossible dates.Tests and battery voltage showed normal values.When re-interrogating again the icd in a new interrogation session, the unjustified warnings disappeared.The icd was interrogated 7 days later showing no unexpected warning and normal tests values.

Manufacturer Narrative

Preliminary analysis results showed that the reported behavior resulted from a wrong data reading due to a disturbed rf communication.

Event Description

Reportedly, the subject icd was interrogated during a standard follow-up some days after implantation.At interrogation, the device showed many unexpected and unjustified warnings with impossible dates.Tests and battery voltage showed normal values.When re-interrogating again the icd in a new interrogation session, the unjustified warnings disappeared.The icd was interrogated 7 days later showing no unexpected warning and normal tests values.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, the subject icd was interrogated during a standard follow-up some days after implantation.At interrogation, the device showed many unexpected and unjustified warnings with impossible dates.Tests and battery voltage showed normal values.When re-interrogating again the icd in a new interrogation session, the unjustified warnings disappeared.The icd was interrogated 7 days later showing no unexpected warning and normal tests values.

• 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: 6456240
• MDR Text Key: 72092105
• Report Number: 1000165971-2017-00280
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2018
• Device Model Number: PLATINIUM DR 1540
• Device Catalogue Number: PLATINIUM DR 1540
• Device Lot Number: S0227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2017
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2016
• 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