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

Model Number	REPLY DR
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The subject pacemaker was implanted on (b)(6) 2017.Reportedly, during a follow-up performed on (b)(6) 2017, the estimated residual longevity was 12 years.The estimated residual longevity was superior to 8 years in (b)(6) 2018 and superior to 7 years on (b)(6) 2018.The patient was concerned that this was not normal battery depletion.It was also observed that the percentage of ventricular pacing of the patient was initially low (about 1%) and increased up to 96 - 98 % after an atrioventricular node ablation.Preliminary analysis revealed that normal battery depletion occurred.
Event or Problem Description
The subject pacemaker was implanted on (b)(6) 2017.Reportedly, during a follow-up performed on september 2017, the estimated residual longevity was 12 years.The estimated residual longevity was superior to 8 years in may 2018 and superior to 7 years on (b)(6) 2018.The patient was concerned that this was not normal battery depletion.It was also observed that the percentage of ventricular pacing of the patient was initially low (about 1%) and increased up to 96 - 98 % after an atrioventricular node ablation.Preliminary analysis revealed that normal battery depletion occurred.

• Brand Name: REPLY
• Common Device Name: 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
• MDR Report Key: 8163570
• Report Number: 1000165971-2018-01060
• Device Sequence Number: 11122007
• Product Code: NVZ
• UDI-Device Identifier: 08031527011523
• UDI-Public: (01)08031527011523(11)161214(17)180122
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P950029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2018
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: S0239
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/19/2018
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1