MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number PARADYM RF SONR CRT-D 9770

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 10/05/2018

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

Reportedly, upon icd interrogation on (b)(6 )2018, the following warning was displayed: ¿[58] last shock energy delivered (j):0.Defibrillation system potentially ineffective¿.The warning was no longer displayed after leads impedance measurements and sensing tests.Preliminary analysis results showed that this warning was inappropriately displayed and occurred due to a wrong reading of the device memory by inductive telemetry during interrogation.

Event Description

Reportedly, upon icd interrogation on (b)(6) 2018, the following warning was displayed: ¿[58] last shock energy delivered (j):0.Defibrillation system potentially ineffective¿.The warning was no longer displayed after leads impedance measurements and sensing tests.Preliminary analysis results showed that this warning was inappropriately displayed and occurred due to a wrong reading of the device memory by inductive telemetry during interrogation.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: PARADYM RF
• Type of Device: DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)
• 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: 8015299
• MDR Text Key: 125609151
• Report Number: 1000165971-2018-00955
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527009261
• UDI-Public: (01)08031527009261(11)141020(17)151120
• 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
• Report Date: 12/17/2018

1 Device was Involved in the Event

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: 11/20/2015
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2856
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2018
• Initial Date Manufacturer Received: 10/05/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1