MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY 200; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number REPLY 200 DR

Device Problem Loss of Data (2903)

Patient Problem No Information (3190)

Event Date 11/13/2017

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 livanova that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, on (b)(6) 2017 a pacemaker replacement procedure was performed.While still in the box, the subject device was reprogrammed to operate at 50 min-1 in aai mode.The pacemaker was then taken out of the package and connected to the atrial and ventricular leads.After the pocket was closed, when the device was interrogated, it was found that aida had not been activated.After ¿aida programming¿ was manually performed in the aida screen, the programming session ended.The pacemaker was then re-interrogated, but aida had still not been activated.The pacing mode was reprogrammed to safer.This time, aida had been activated and statistical data such as the pacing rate had been recorded.With the pacing mode remaining in safer, the basic rate was programmed to 50 min-1 (max.130 min-1).On (b)(6) 2017 the device was interrogated; however, no data had been recorded in the device memory.The pacemaker was reprogrammed back to aai mode without no further examination regarding the behavior related to aida.After the pacemaker was reprogrammed from safer mode to operate in aai mode at 50 min-1, aida programming was performed to ensure a proper activation of aida.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, on (b)(6) 2017 a pacemaker replacement procedure was performed.While still in the box, the subject device was reprogrammed to operate at 50 min-1 in aai mode.The pacemaker was then taken out of the package and connected to the atrial and ventricular leads.After the pocket was closed, when the device was interrogated, it was found that aida had not been activated.After ¿aida programming¿ was manually performed in the aida screen, the programming session ended.The pacemaker was then re-interrogated, but aida had still not been activated.The pacing mode was reprogrammed to safer.This time, aida had been activated and statistical data such as the pacing rate had been recorded.With the pacing mode remaining in safer, the basic rate was programmed to 50 min-1 (max.130 min-1).On (b)(6) 2017 the device was interrogated; however, no data had been recorded in the device memory.The pacemaker was reprogrammed back to aai mode without no further examination regarding the behavior related to aida.After the pacemaker was reprogrammed from safer mode to operate in aai mode at 50 min-1, aida programming was performed to ensure a proper activation of aida.

Manufacturer Narrative

Preliminary analysis did not reveal any device malfunction.

Event Description

Reportedly, on (b)(6) 2017 a pacemaker replacement procedure was performed.While still in the box, the subject device was reprogrammed to operate at 50 min-1 in aai mode.The pacemaker was then taken out of the package and connected to the atrial and ventricular leads.After the pocket was closed, when the device was interrogated, it was found that aida had not been activated.After ¿aida programming¿ was manually performed in the aida screen, the programming session ended.The pacemaker was then re-interrogated, but aida had still not been activated.The pacing mode was reprogrammed to safer.This time, aida had been activated and statistical data such as the pacing rate had been recorded.With the pacing mode remaining in safer, the basic rate was programmed to 50 min-1 (max.130 min-1).On (b)(6) 2017 the device was interrogated; however, no data had been recorded in the device memory.The pacemaker was reprogrammed back to aai mode without no further examination regarding the behavior related to aida.After the pacemaker was reprogrammed from safer mode to operate in aai mode at 50 min-1, aida programming was performed to ensure a proper activation of aida.

Manufacturer Narrative

Additional analysis confirmed that device memory was unexpectedly deactivated.

Event Description

Reportedly, on (b)(6) 2017 a pacemaker replacement procedure was performed.While still in the box, the subject device was reprogrammed to operate at 50 min-1 in aai mode.The pacemaker was then taken out of the package and connected to the atrial and ventricular leads.After the pocket was closed, when the device was interrogated, it was found that aida had not been activated.After ¿aida programming¿ was manually performed in the aida screen, the programming session ended.The pacemaker was then re-interrogated, but aida had still not been activated.The pacing mode was reprogrammed to safer.This time, aida had been activated and statistical data such as the pacing rate had been recorded.With the pacing mode remaining in safer, the basic rate was programmed to 50 min-1 (max.130 min-1).On (b)(6) 2017 the device was interrogated; however, no data had been recorded in the device memory.The pacemaker was reprogrammed back to aai mode without no further examination regarding the behavior related to aida.After the pacemaker was reprogrammed from safer mode to operate in aai mode at 50 min-1, aida programming was performed to ensure a proper activation of aida.

• Brand Name: REPLY 200
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 7107605
• MDR Text Key: 95747416
• Report Number: 1000165971-2017-00915
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012933
• UDI-Public: (01)08031527012933(11)170907(17)190907
• 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,Followup,Followup
• Report Date: 11/15/2017

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: Physician
• Device Expiration Date: 09/07/2019
• Device Model Number: REPLY 200 DR
• Device Catalogue Number: REPLY 200 DR
• Device Lot Number: S0280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/15/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 12/08/2017; 01/08/2018; 03/06/2018
• Supplement Dates FDA Received: 01/03/2018; 02/04/2018; 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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