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 12/01/2017

Event Type  Injury  

Event Description

At the time of changing the device, it was impossible to unscrew the connector to release the atrial lead.The lead was cut due to an infection risk.Another device and atrial lead were implanted.

Manufacturer Narrative

Preliminary review of the device history records showed no irregularity.

Event Description

At the time of changing the device, it was impossible to unscrew the connector to release the atrial lead.The lead was cut due to an infection risk.Another device and atrial lead were implanted.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

At the time of changing the device, it was impossible to unscrew the connector to release the atrial lead.The lead was cut due to an infection risk.Another device and atrial lead were implanted.The physician has cut the header to try to unscrew the lead.This part was thrown away to only keep the can.

• 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: 7141518
• MDR Text Key: 95587016
• Report Number: 1000165971-2017-00952
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2017

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: 02/03/2010
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/04/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/10/2018; 02/19/2018
• Supplement Dates FDA Received: 02/02/2018; 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2008
• 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