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

Model Number PLATINIUM SONR CRT-D 1811

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Information (3190)

Event Date 12/09/2018

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

On (b)(6) 2017, the subject crt-d was implanted and connected to the previously implanted leads.Reportedly, on (b)(6) 2019, the sales representative was warned that the crt-d displayed a charge time of 0.3 seconds during the interrogation.Review of the patient files revealed that a shock of 42 joules was delivered on (b)(6) 2018.The physicians suspected that the shock was delivered because of electromagnetic interferences (emi), since noise was observed on both the atrial and ventricular channels.As the noise was intermittent, the capacitors could have been charging discontinuously until a shock was delivered.It was supposed that the charge time of 0.3 seconds was due to previous charging of the capacitors.Preliminary analysis revealed that the atrial and ventricular noise oversensing most probably resulted from electromagnetic interferences (emi).

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

On (b)(6)2017 , the subject crt-d was implanted and connected to the previously implanted leads.Reportedly, on (b)(6)2019 , the sales representative was warned that the crt-d displayed a charge time of 0.3 seconds during the interrogation.Review of the patient files revealed that a shock of 42 joules was delivered (b)(6)2018.The physicians suspected that the shock was delivered because of electromagnetic interferences (emi), since noise was observed on both the atrial and ventricular channels.As the noise was intermittent, the capacitors could have been charging discontinuously until a shock was delivered.It was supposed that the charge time of 0.3 seconds was due to previous charging of the capacitors.Preliminary analysis revealed that the atrial and ventricular noise oversensing most probably resulted from electromagnetic interferences (emi).

Manufacturer Narrative

Based on preliminary analysis, the displayed charge time was normal.

Event Description

On (b)(6)2017, the subject crt-d was implanted and connected to the previously implanted leads.Reportedly, on (b)(6)2019, the sales representative was warned that the crt-d displayed a charge time of 0.3 seconds during the interrogation.Review of the patient files revealed that a shock of 42 joules was delivered on 9 december 2018.The physicians suspected that the shock was delivered because of electromagnetic interferences (emi), since noise was observed on both the atrial and ventricular channels.As the noise was intermittent, the capacitors could have been charging discontinuously until a shock was delivered.It was supposed that the charge time of 0.3 seconds was due to previous charging of the capacitors.Preliminary analysis revealed that the atrial and ventricular noise oversensing most probably resulted from electromagnetic interferences (emi).

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
• 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: 8560282
• MDR Text Key: 145513076
• Report Number: 1000165971-2019-00260
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(11)161128(17)180628
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: PLATINIUM SONR CRT-D 1811
• Device Lot Number: S0236
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/03/2019
• Event Location: Hospital
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1