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

Model Number REPLY DR

Device Problem Connection Problem (2900)

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

Event Date 06/22/2017

Event Type  Injury  

Event Description

Connection issues were noted during the implant attempt of the subject pacemaker.Connecting the atrial lead was initially not possible.Turning the atrial setscrew counterclockwise helped to introduce this lead, the pin passed through the connector block.However the v lead could not be introduced in the corresponding cavity.Even after unscrewing the v setscrew (counterclockwise) the lead could not be introduced further in the connector block.The subject pacemaker was replaced.

Manufacturer Narrative

Please refer to the attached investigation report.(b)(4).

Event Description

Connection issues were noted during the implant attempt of the subject pacemaker.Connecting the atrial lead was initially not possible.Turning the atrial setscrew counterclockwise helped to introduce this lead, the pin passed through the connector block.However the v lead could not be introduced in the corresponding cavity.Even after unscrewing the v setscrew (counterclockwise) the lead could not be introduced further in the connector block.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: 6696345
• MDR Text Key: 79354239
• Report Number: 1000165971-2017-00547
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 08031527008882
• UDI-Public: (01)08031527008882(11)170313(17)181013
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 06/26/2017

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: 10/13/2018
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: S0254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/26/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2017
• 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
• Patient Outcome(s): Required Intervention