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

Model Number CPR3

Device Problem Communication or Transmission Problem (2896)

Patient Problem Dizziness (2194)

Event Date 05/08/2020

Event Type  malfunction  

Event Description

Reportedly, the associated crt-d was implanted on (b)(6) 2020.During an interrogation performed on (b)(6) 2020, issues were encountered with the inductive telemetry and a pop-up message indicating a device re-initialization was displayed.The device was re-initialized three times.The device was programmed in ooo mode, with atp and shocks deactivated, but was pacing in vvi mode with a basic rate set at 60min-1.The patient did not undergo any mri scan.Another re-initialization occurred when the device was subsequently interrogated with another programmer.Normal functioning was observed afterwards, and no anomaly was observed during real time tests.The subject cpr3 head, used during the interrogation of the crt-d, was returned for analysis.Preliminary analysis results on the associated crt-d confirmed that four device resets occurred during the follow-up performed on (b)(6) 2020.These resets were caused by a very specific and rare communication error that occurred upon device interrogation.Preliminary analysis results showed that the performances of the subject cpr3 head were within specifications.No anomaly is suspected on the subject cpr3 head.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, the associated crt-d was implanted on 04 may 2020.During an interrogation performed on 08 may 2020, issues were encountered with the inductive telemetry and a pop-up message indicating a device re-initialization was displayed.The device was re-initialized three times.The device was programmed in ooo mode, with atp and shocks deactivated, but was pacing in vvi mode with a basic rate set at 60min-1.The patient did not undergo any mri scan.Another re-initialization occurred when the device was subsequently interrogated with another programmer.Normal functioning was observed afterwards, and no anomaly was observed during real time tests.The subject cpr3 head, used during the interrogation of the crt-d, was returned for analysis.Preliminary analysis results on the associated crt-d confirmed that four device resets occurred during the follow-up performed on 08 may 2020.These resets were caused by a very specific and rare communication error that occurred upon device interrogation.Preliminary analysis results showed that the performances of the subject cpr3 head were within specifications.No anomaly is suspected on the subject cpr3 head.

• 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: 10178472
• MDR Text Key: 196476413
• Report Number: 1000165971-2020-00440
• 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
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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
• Device Operator: Health Professional
• Device Model Number: CPR3
• Device Catalogue Number: CPR3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/28/2020
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1