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

Model Number CPR3

Device Problem Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2017

Event Type  malfunction  

Event Description

During an incoming inspection the cpr3 inductive telemetry head was connected to an orchestra plus programmer; then, an abnormal beep tone was heard from the programming head.The product was therefore determined to be non-conforming.Note: this abnormality was not encountered with other cpr3 inductive telemetry heads that were inspected using the same orchestra plus programmer.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

During an incoming inspection the cpr3 inductive telemetry head was connected to an orchestra plus programmer; then, an abnormal beep tone was heard from the programming head.The product was therefore determined to be non-conforming.Note: this abnormality was not encountered with other cpr3 inductive telemetry heads that were inspected using the same orchestra plus 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
• Manufacturer (Section G): EOLANE BLD J. BAPTISTE COLBERT 49520 COMBREE FRANCE; 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: 7040599
• MDR Text Key: 93220277
• Report Number: 1000165971-2017-00850
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CPR3
• Device Catalogue Number: CPR3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2017
• Event Location: Other
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1