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 Problem Programming Issue (3014)

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

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reportedly, the physician wanted to program the device in a mri mode auto in ooo, but he was not able to do it.An error message was displayed stating that programming was not possible.

Event Description

Reportedly, the physician wanted to program the device in a mri mode auto in ooo, but he was not able to do it.An error message was displayed stating that programming was not possible.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, the physician wanted to program the device in a mri mode auto in ooo, but he was not able to do it.An error message was displayed stating that programming was not possible.

Manufacturer Narrative

Health professional? corrected.Point 3) of recommendation in the analysis report corrected.(b)(4).

Event Description

Reportedly, the physician wanted to program the device in a mri mode auto in ooo, but he was not able to do it.An error message was displayed stating that programming was not possible.

• 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: 6985054
• MDR Text Key: 91100518
• Report Number: 1000165971-2017-00795
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012919
• UDI-Public: (01)08031527012919(11)160113(17)170813
• 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,Followup,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2017
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Device Lot Number: S0140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/29/2017
• Event Location: Hospital
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2016
• 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