MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY 200

Model Number REPLY 200 SR

Device Problem Failure to Transmit Record (1521)

Patient Problem Ventricular Tachycardia (2132)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

During the night between (b)(6) 2016, the patient, implanted with the subject pacemaker, was transported to the hospital due to ventricular fibrillation.The pacemaker was interrogated on (b)(6) 2016 at 08:54.Some episodes showing ventricular undersensing were recorded in the device memories.Therefore, ventricular sensitivity threshold was reprogrammed from 2mv to 1.2mv.Reportedly, ventricular tachycardia was observed on the ecg monitor in the morning.Pacemaker was interrogated again, but there was no trace of the ventricular tachycardia event which occurred in the morning in the device memories.Preliminary analysis confirmed that the pacemaker did not detect any tachycardia, most probably because events sensed by the pacemaker did not meet the criteria required for detecting and/or recording a ventricular burst episode.

Manufacturer Narrative

(b)(4).

Event Description

During the night between (b)(6) 2016, the patient, implanted with the subject pacemaker, was transported to the hospital due to ventricular fibrillation.The pacemaker was interrogated on (b)(6) 2016 at 08:54.Some episodes showing ventricular undersensing were recorded in the device memories.Therefore, ventricular sensitivity threshold was reprogrammed from 2mv to 1.2mv.Reportedly, ventricular tachycardia was observed on the ecg monitor in the morning.Pacemaker was interrogated again, but there was no trace of the ventricular tachycardia event which occurred in the morning in the device memories.Preliminary analysis confirmed that the pacemaker did not detect any tachycardia, most probably because events sensed by the pacemaker did not meet the criteria required for detecting and/or recording a ventricular burst episode.

• Brand Name: REPLY 200
• 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: 5577231
• MDR Text Key: 43296852
• Report Number: 1000165971-2016-00215
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 12/11/2016
• Device Model Number: REPLY 200 SR
• Device Catalogue Number: REPLY 200 SR
• Device Lot Number: S0080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/22/2016
• Event Location: Hospital
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• 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