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

Model Number ESPRIT DR

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem Death (1802)

Event Date 11/12/2019

Event Type  Injury  

Event Description

Reportedly, the subject pacemaker was implanted on (b)(6) 2010.On (b)(6) 2019, during a follow-up, the displayed residual longevity was 1 year and 6 months (minimum 12 months).The magnet rate was 96min-1 and the battery impedance was 2.85kohms.The patient died on (b)(6) 2019.On (b)(6) 2019, the pacemaker was interrogated at the mortuary.It was observed that the device had reached the recommended replacement time (rrt) and was programmed in vvi mode, 70min-1.The magnet rate was 70min-1 and the battery impedance was 18.43kohms.

Event Description

Reportedly, the subject pacemaker was implanted on (b)(6) 2010.On (b)(6) 2019, during a follow-up, the displayed residual longevity was 1 year and 6 months (minimum 12 months).The magnet rate was 96min-1 and the battery impedance was 2.85kohms.The patient died on (b)(6) 2019.On (b)(6) 2019, the pacemaker was interrogated at the mortuary.It was observed that the device had reached the recommended replacement time (rrt) and was programmed in vvi mode, 70min-1.The magnet rate was 70min-1 and the battery impedance was 18.43kohms.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20200313 - file-2019-04324 - analysis_and_closure_report_resp-2020-00282.Pdf].

• 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
• MDR Report Key: 9568430
• MDR Text Key: 174267430
• Report Number: 1000165971-2020-00218
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2012
• Device Model Number: ESPRIT DR
• Device Catalogue Number: ESPRIT DR
• Device Lot Number: 2482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/16/2019
• Event Location: Other
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death