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

Model Number REPLY DR

Device Problems Intermittent Capture (1080); Over-Sensing (1438)

Patient Problem No Information (3190)

Event Date 12/05/2017

Event Type  Injury  

Event Description

The subject pacemaker and two (non-sorin) leads were implanted on (b)(6) 2011.Reportedly, in 2016, the use of the atrial lead was discontinued due to a conductor fracture and the pacing mode was reprogrammed from ddd to vvi.During a follow-up performed on (b)(6) 2017, normal ventricular lead measurements were observed.However, abnormal signals, looking like pacing pulses, were observed at unexpected timings on ecg examination, with the patient lying on her back.Reportedly, when the mv sensor was reprogrammed to off, the aforementioned signals stopped appearing on the egm.Intermittent ventricular loss of pacing was also suspected from the episodes recorded in device memory, mostly during night time.In addition, regarding the atrial channel: - overshoot waveforms were intermittently observed on the egm and in the recorded episodes.- non-physiological pulses were recorded at an interval of 125 ms.Preliminary analysis results revealed that a lead to lead abrasion is suspected.

Manufacturer Narrative

Please refer to the analysis report.(b)(4).

Event Description

The subject pacemaker and two (non-sorin) leads were implanted on (b)(6) 2011.Reportedly, in 2016, the use of the atrial lead was discontinued due to a conductor fracture and the pacing mode was reprogrammed from ddd to vvi.During a follow-up performed on (b)(6) 2017, normal ventricular lead measurements were observed.However, abnormal signals, looking like pacing pulses, were observed at unexpected timings on ecg examination, with the patient lying on her back.Reportedly, when the mv sensor was reprogrammed to off, the aforementioned signals stopped appearing on the egm.Intermittent ventricular loss of pacing was also suspected from the episodes recorded in device memory, mostly during night time.In addition, regarding the atrial channel: - overshoot waveforms were intermittently observed on the egm and in the recorded episodes.- non-physiological pulses were recorded at an interval of 125 ms.Preliminary analysis results revealed that a lead to lead abrasion is suspected.

• 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: 7153778
• MDR Text Key: 96005963
• Report Number: 1000165971-2017-00972
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

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: Medical Technologist
• Device Expiration Date: 07/22/2012
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/08/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2010
• 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