MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY CPR3; PROGRAMMER, PACEMAKER

Model Number CPR3

Device Problem Interrogation Problem (4017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2020

Event Type  malfunction  

Event Description

Reportedly, it was not possible to interrogate a pacemaker with the subject inductive telemetry head and the associated programmer.No green leds were lit when the programming head was placed over the implant.This pacemaker could be successfully interrogated with another programmer and another inductive telemetry head.Other pacemakers could successfully be interrogated with the subject inductive telemetry head and the associated programmer.

Manufacturer Narrative

Expertise files analysis confirmed the reported behavior and revealed that it could be due to telemetry errors during interrogation, which could result from an improper positioning of the inductive head over the implantation site.No issue is suspected on the programmer or on the inductive telemetry head.

Event Description

Reportedly, it was not possible to interrogate a pacemaker with the subject inductive telemetry head and the associated programmer.No green leds were lit when the programming head was placed over the implant.This pacemaker could be successfully interrogated with another programmer and another inductive telemetry head.Other pacemakers could successfully be interrogated with the subject inductive telemetry head and the associated programmer.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, it was not possible to interrogate a pacemaker with the subject inductive telemetry head and the associated programmer.No green leds were lit when the programming head was placed over the implant.This pacemaker could be successfully interrogated with another programmer and another inductive telemetry head.Other pacemakers could successfully be interrogated with the subject inductive telemetry head and the associated programmer.

• Brand Name: CPR3
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 10258611
• MDR Text Key: 198963277
• Report Number: 1000165971-2020-00503
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CPR3
• Device Catalogue Number: CPR3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2020
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1