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 12/11/2014

Event Type  Injury  

Event Description

Reportedly, a premature battery depletion is suspected for the subject pacemaker.Device should be removed in two months and will be returned for analysis.No patient consequence as of today.

Event Description

Reportedly, a premature battery depletion is suspected for the subject pacemaker.Device should be removed in two months and will be returned for analysis.No patient consequence as of today.

Event Description

Reportedly, a premature battery depletion is suspected for the subject pacemaker.Device should be removed in two months and will be returned for analysis.No patient consequence as of today.

Manufacturer Narrative

Finally the device was explanted and received 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 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: 4324971
• MDR Text Key: 5136157
• Report Number: 1000165971-2014-00693
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PP950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2014

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: 06/22/2009
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/11/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/20/2015; 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2007
• 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