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

Model Number REPLY DR

Device Problem Under-Sensing (1661)

Patient Problems Atrial Fibrillation (1729); Electric Shock (2554)

Event Date 11/22/2016

Event Type  Injury  

Event Description

After applying two cardioversions following manual requirements, the physician interrogated the subject pacemaker to perform tests.Abnormal egms and markers were reportedly observed during sensitivity tests and threshold tests.After repeating the tests several times, normal behavior was observed.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

After applying two cardioversions following manual requirements, the physician interrogated the subject pacemaker to perform tests.Abnormal egms and markers were reportedly observed during sensitivity tests and threshold tests.After repeating the tests several times, normal behavior was observed.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL (SALUGGIA ITALY); 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6184048
• MDR Text Key: 62678324
• Report Number: 1000165971-2016-00825
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P950029
• 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: 11/22/2016

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: 06/18/2016
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: S0058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/17/2016
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• 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
• Patient Outcome(s): Required Intervention