MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ESPRIT SR

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2017

Event Type  Injury  

Event Description

Physician reported that a during scheduled follow up, he detected that the ventricular lead had no capture and no sensing.The x-ray showed that lead connector was no longer completely inserted in the pacemaker lead port.During revision he was not able to push the lead completely back inside the pacemaker port, although the screw was adequately released.For this reason he replaced the pacemaker by a new device.

Manufacturer Narrative

Preliminary analysis of the returned device confirmed proper electrical and mechanical function.Visual inspection showed no tightening mark on the set-screw tip.

Event Description

Physician reported that a during scheduled follow up, he detected that the ventricular lead had no capture and no sensing.The x-ray showed that lead connector was no longer completely inserted in the pacemaker lead port.During revision he was not able to push the lead completely back inside the pacemaker port, although the screw was adequately released.For this reason he replaced the pacemaker by a new device.

Event Description

Physician reported that a during scheduled follow up, he detected that the ventricular lead had no capture and no sensing.The x-ray showed that lead connector was no longer completely inserted in the pacemaker lead port.During revision he was not able to push the lead completely back inside the pacemaker port, although the screw was adequately released.For this reason he replaced the pacemaker by a new device.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 7036363
• MDR Text Key: 92155198
• Report Number: 1000165971-2017-00853
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527009148
• UDI-Public: (01)08031527009148(11)160915(17)180415
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2018
• Device Model Number: ESPRIT SR
• Device Catalogue Number: ESPRIT SR
• Device Lot Number: S0219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 12/01/2017; 12/29/2017
• Supplement Dates FDA Received: 12/20/2017; 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• 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
• Patient Outcome(s): Required Intervention