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

Model Number REPLY DR

Device Problem Failure to Transmit Record (1521)

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

Event Date 08/28/2014

Event Type  malfunction  

Event Description

Reportedly, during a routine reply dr follow-up, the programmer (sn: (b)(4)) was closed down and turned off.When the programmer was turned on by the user, it was not possible to access patient¿s file and the following message was displayed to the user: ¿the corresponding programmer is not available.Please contact your sorin crm sales representative for upgrade¿ and the device model was also marked as ¿unknown¿.It was reported that the other patient¿s files were available.No other issue was observed on this programmer.

Event Description

Reportedly, during a routine reply dr follow-up, the programmer (sn: (b)(4)) was closed down and turned off.When the programmer was turned on by the user, it was not possible to access patient¿s file and the following message was displayed to the user: ¿the corresponding programmer is not available.Please contact your sorin crm sales representative for upgrade¿ and the device model was also marked as ¿unknown.¿ it was reported that the other patient¿s files were available.No other issue was observed on this programmer.

Event Description

Reportedly, during a routine reply dr follow-up on (b)(6) 2014, the programmer (sn: (b)(4)) was closed down and turned off.When the programmer was turned on by the user, it was not possible to access patient files and the following message was displayed to the user: ¿the corresponding programmer is not available.Please contact your sorin crm sales representative for upgrade¿ and the device model was also marked as ¿unknown¿.No other issue was observed on this programmer.

Manufacturer Narrative

Preliminary analysis showed the reported event is related to a programmer software issue; however, there is no impact on pacemaker operation.

• 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 9214 0; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 4122824
• MDR Text Key: 4794247
• Report Number: 1000165971-2014-00551
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PP950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2014

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: 11/27/2011
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/29/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 09/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/12/2014; 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2010
• 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