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 1841

Device Problems High impedance (1291); Failure to Interrogate (1332); Nonstandard Device (1420); Over-Sensing (1438); Communication or Transmission Problem (2896)

Patient Problem No Information (3190)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

Recall pending.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

Reportedly, the crt-d could not be interrogated on (b)(6) 2018 with two different programmers.Ventricular pacing spikes followed by spontaneous atrial waves were observed on an ecg.Since the patient is usually followed in another center, it is unknown if the patient is pacing-dependent or if he has a history of rhythm disorder.Despite the fact that the crt-d could not be interrogated, the patient returned back home.Preliminary analysis confirmed an inductive telemetry blockage.Patient files analysis revealed non-physiological signals on the ventricular channel.A ventricular lead issue and/or a lead/crt-d connection issue at ventricular level is suspected.However, a crt-d issue could not be excluded.Patient care recommendations have been provided on 27 july 2018 to perform a recovery procedure on this device and to evaluate the benefit of a re-intervention.

Event Description

Reportedly, the crt-d could not be interrogated on (b)(6) 2018 with two different programmers.Ventricular pacing spikes followed by spontaneous atrial waves were observed on an ecg.Since the patient is usually followed in another center, it is unknown if the patient is pacing-dependent or if he has a history of rhythm disorder.Despite the fact that the crt-d could not be interrogated, the patient returned back home.Preliminary analysis confirmed an inductive telemetry blockage.Patient files analysis revealed non-physiological signals on the ventricular channel.A ventricular lead issue and/or a lead/crt-d connection issue at ventricular level is suspected.However, a crt-d issue could not be excluded.Patient care recommendations have been provided on (b)(6) 2018 to perform a recovery procedure on this device and to evaluate the benefit of a re-intervention.

Manufacturer Narrative

The device involved in this mdr report is not included in any recall reported to fda.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, the crt-d could not be interrogated on (b)(6) 2018 with two different programmers.Ventricular pacing spikes followed by spontaneous atrial waves were observed on an ecg.Since the patient is usually followed in another center, it is unknown if the patient is pacing-dependent or if he has a history of rhythm disorder.Despite the fact that the crt-d could not be interrogated, the patient returned back home.Preliminary analysis confirmed an inductive telemetry blockage.Patient files analysis revealed non-physiological signals on the ventricular channel.A ventricular lead issue and/or a lead/crt-d connection issue at ventricular level is suspected.However, a crt-d issue could not be excluded.Patient care recommendations have been provided on (b)(6) 2018 to perform a recovery procedure on this device and to evaluate the benefit of a re-intervention.

• 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: 7761764
• MDR Text Key: 117019736
• Report Number: 1000165971-2018-00723
• Device Sequence Number: 0
• Product Code: NIK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2018
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 05/30/2017
• Device Model Number: PLATINIUM SONR CRT-D 1841
• Device Catalogue Number: PLATINIUM SONR CRT-D 1841
• Device Lot Number: S0124
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2018
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/15/2018; 08/31/2018
• Supplement Dates FDA Received: 08/24/2018; 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1