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

Model Number REPLY DR

Device Problem Over-Sensing (1438)

Patient Problem No Information (3190)

Event Date 12/06/2017

Event Type  Injury  

Event Description

The pacemaker and the two (non-sorin) leads were implanted on (b)(6) 2011.Reportedly, while no abnormalities were observed on the ventricular lead measurements, several v burst episodes showing abnormal waveforms were recorded in the device memory during a follow-up performed on (b)(6) 2017.Damage to the ventricular lead was suspected.The next follow-up, during which future treatment will be discussed with the patient, was scheduled for (b)(6) 2018.Preliminary analysis confirmed the reported ventricular oversensing.It most probably resulted from a lead issue and/or a lead-pacemaker connection issue at ventricular level.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

The pacemaker and the two (non-sorin) leads were implanted on (b)(6) 2011.Reportedly, while no abnormalities were observed on the ventricular lead measurements, several v burst episodes showing abnormal waveforms were recorded in the device memory during a follow-up performed on (b)(6) 2017.Damage to the ventricular lead was suspected.The next follow-up, during which future treatment will be discussed with the patient, was scheduled for (b)(6) 2018.Preliminary analysis confirmed the reported ventricular oversensing.It most probably resulted from a lead issue and/or a lead-pacemaker connection issue at ventricular level.

• 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: 7150707
• MDR Text Key: 95913298
• Report Number: 1000165971-2017-00968
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/11/2017

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: Physician
• Device Expiration Date: 01/11/2013
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/11/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2011
• 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