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

Model Number REPLY DR

Device Problem Low Battery (2584)

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

Event Date 02/02/2016

Event Type  Injury  

Event Description

Reportedly, the subject device was explanted during a lead revision due to lead fracture.The battery impedance was 3.8kohm.The device should be returned for analysis.

Manufacturer Narrative

Preliminary analysis showed that the device operated as specified.

Event Description

Reportedly, the subject device was explanted during a lead revision due to lead fracture.The battery impedance was 3.8kohm.The device should be returned for analysis.

Event Description

Reportedly, the subject device was explanted during a lead revision due to lead fracture.The battery impedance was 3.8kohm.The device should be returned for analysis.

• 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: 5470548
• MDR Text Key: 39370859
• Report Number: 1000165971-2016-00109
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/02/2016

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: 04/12/2013
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/02/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 03/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/14/2016; 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2011
• 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