MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number KORA 250 DR

Device Problems Failure to Transmit Record (1521); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, the subject pacemaker was interrogated without any issue on (b)(6) 2016.Then the pacemaker was interrogated on (b)(6) 2016 and real time tests were performed.However, it was not possible to read aida (device memories) and to fill patient data.The programmer was displaying ¿aida reading¿ at the top of the screen, and a message indicating telemetry issues was also displayed several times.After removing and repositioning the telemetry head several times, device memories could still not be read.The session was ended and the programmer was restarted.Upon re-interrogation of the pacemaker, device memories could be read without any issue.

Event Description

Reportedly, the subject pacemaker was interrogated without any issue on (b)(6) 2016.Then the pacemaker was interrogated on (b)(6) 2016 and real time tests were performed.However, it was not possible to read aida (device memories) and to fill patient data.The programmer was displaying ¿aida reading¿ at the top of the screen, and a message indicating telemetry issues was also displayed several times.After removing and repositioning the telemetry head several times, device memories could still not be read.The session was ended and the programmer was restarted.Upon re-interrogation of the pacemaker, device memories could be read without any issue.

• Brand Name: KORA
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; 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: 6192751
• MDR Text Key: 63326030
• Report Number: 1000165971-2016-00843
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2018
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Device Lot Number: S0198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/25/2016
• Event Location: Hospital
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1