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

Model Number ESPRIT SR

Device Problem Failure to Transmit Record (1521)

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

Event Date 04/07/2014

Event Type  malfunction  

Event Description

Reportedly, the physician noticed that during the first interrogation at implantation after saving the impedance, threshold and sensing measurements, these measurement values did not appear in the printouts.They appeared in the following interrogations.

Manufacturer Narrative

(b)(4).

Event Description

Reportedly, the physician noticed that during the first interrogation at implantation after saving the impedance, threshold and sensing measurements, these measurement values did not appear in the printouts.They appeared in the following interrogations.

• 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: 3808370
• MDR Text Key: 4646867
• Report Number: 1000165971-2014-00250
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PP950029
• 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: 04/15/2014

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: Physician
• Device Expiration Date: 08/29/2015
• Device Model Number: ESPRIT SR
• Device Catalogue Number: ESPRIT SR
• Device Lot Number: 2796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/15/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 05/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• 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