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

Model Number REPLY D

Device Problem Connection Problem (2900)

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

Event Date 10/27/2017

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

During the implant attempt of the subject pacemaker, the physician experiences difficulties in inserting lead in the ventricular channel, feeling a mechanical obstacle.He observed the same issue with two different leads.As a check, he inserts the lead connector of both leads in the atrial channel, not observing any kind of problem.The subject pacemaker was replaced.

Manufacturer Narrative

Preliminary evaluation of the returned device showed proper mechanical and electrical operation.Visual inspection showed no lead tightening marks on each set-screw and damage to the first thread of the ventricular set-screw.

Event Description

During the implant attempt of the subject pacemaker, the physician experiences difficulties in inserting lead in the ventricular channel, feeling a mechanical obstacle.He observed the same issue with two different leads.As a check, he inserts the lead connector of both leads in the atrial channel, not observing any kind of problem.The subject pacemaker was replaced.

Manufacturer Narrative

(b)(4).

Event Description

During the implant attempt of the subject pacemaker, the physician experiences difficulties in inserting lead in the ventricular channel, feeling a mechanical obstacle.He observed the same issue with two different leads.As a check, he inserts the lead connector of both leads in the atrial cannel, not observing any kind of problem.The subject pacemaker was replaced.

• 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: 7104010
• MDR Text Key: 95180974
• Report Number: 1000165971-2017-00912
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527008998
• UDI-Public: (01)08031527008998(11)170622(17)190122
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 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: Health Professional
• Device Expiration Date: 01/22/2019
• Device Model Number: REPLY D
• Device Catalogue Number: REPLY D
• Device Lot Number: S0271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• 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: 12/11/2017
• Supplement Dates Manufacturer Received: 12/14/2017; 01/25/2018
• Supplement Dates FDA Received: 01/08/2018; 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2017
• 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