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 Loss of Data (2903)

Patient Problem No Information (3190)

Event Date 09/14/2018

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, during a standard follow-up on (b)(6) 2018, patient information was found to be blank on a printout.It was reported that telemetry errors occurred multiple times during interrogation of the device and the programming head was repositioned.A review of the patient data from the last pacemaker interrogation revealed that the patient information had been properly entered.Preliminary analysis confirmed the reported event.

Event Description

Reportedly, during a standard follow-up on (b)(6) 2018, patient information was found to be blank on a printout.It was reported that telemetry errors occurred multiple times during interrogation of the device and the programming head was repositioned.A review of the patient data from the last pacemaker interrogation revealed that the patient information had been properly entered.Preliminary analysis confirmed the reported event.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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
• MDR Report Key: 7934054
• MDR Text Key: 122808427
• Report Number: 1000165971-2018-00903
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527014586
• UDI-Public: (01)08031527014586(11)160701(17)180701
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

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 Expiration Date: 07/01/2018
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Device Lot Number: S0199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 10/10/2018
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1