MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY

Model Number REPLY VDR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Failure (2206)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

The device model 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) 2015, on a follow-up performed on a patient with background of atrial fibrillation, all the measurements were normal.In order to promote the spontaneous rhythm, different atrio ventricular (av) intervals were programmed and the patient started to feel bad.When programming the av interval to 230/170 with a frequency of 50 min-1, according to the physician, when clicking on the "program" button, the programmer head was moved from the correct position and then telemetry was lost.At that moment the patient suffered a heart failure with loss of sphincter muscle control and a cardiac resuscitation was needed.The patient recovered especially when vvi mode at 80min-1 was programmed.Preliminary analysis showed that retrograde (va) conduction was observed within the follow-up.This may have been caused by the application of asynchronous modes during the tests performed within the follow-up and/or modifications of timing parameters (rates and/or avd) as reported and confirmed through files analysis.The retrograde conduction was not observed anymore at the end of the follow-up.

Event Description

On september 16th, 2015, on a follow-up performed on a patient with background of atrial fibrillation, all the measurements were normal.In order to promote the spontaneous rhythm, different atrio ventricular (av) intervals were programmed and the patient started to feel bad.When programming the av interval to 230/170 with a frequency of 50 min-1, according to the physician, when clicking on the ¿program¿ button, the programmer head was moved from the correct position and then telemetry was lost.At that moment, the patient suffered a heart failure with loss of sphincter muscle control and a cardiac resuscitation was needed.The patient recovered especially when vvi mode at 80min-1 was programmed.Preliminary analysis showed that retrograde (va) conduction was observed within the follow-up.This may have been caused by the application of asynchronous modes during the tests performed within the follow-up and/or modifications of timing parameters (rates and/or avd) as reported and confirmed through files analysis.The retrograde conduction was not observed anymore at the end of the follow-up.

• Brand Name: REPLY
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 5130362
• MDR Text Key: 27933922
• Report Number: 1000165971-2015-00590
• Device Sequence Number: 1
• Product Code: CEO
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/07/2014
• Device Model Number: REPLY VDR
• Device Catalogue Number: REPLY VDR
• Device Lot Number: 2693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/16/2015
• Event Location: Hospital
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2013
• 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