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

Model Number KORA 100 DR

Device Problem Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

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, no patient file was stored on the programmer after performing the follow-up.The expertise files could not be retrieved due to an ¿error in archiving files¿.

Manufacturer Narrative

Preliminary analysis showed that the reported event could be due to a wrong manipulation when using the programmer.However, more files are requested to finalize the analysis.

Event Description

Reportedly, no patient file was stored on the programmer after performing the follow-up.The expertise files could not be retrieved due to an ¿error in archiving files¿.

Manufacturer Narrative

(b)(4).

Event Description

Reportedly, no patient file was stored on the programmer after performing the follow-up.The expertise files could not be retrieved due to an ¿error in archiving files¿.

• 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: 7385292
• MDR Text Key: 104044816
• Report Number: 1000165971-2018-00318
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012711
• UDI-Public: (01)08031527012711(11)150420(17)161120
• 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,Followup
• Report Date: 06/08/2018

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: 11/20/2016
• Device Model Number: KORA 100 DR
• Device Catalogue Number: KORA 100 DR
• Device Lot Number: S0077
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/12/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 04/11/2018; 05/28/2018
• Supplement Dates FDA Received: 04/23/2018; 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1