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

Model Number KORA 100 SR

Device Problem Loss of Data (2903)

Patient Problem No Information (3190)

Event Date 10/24/2019

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 pacing system was implanted on (b)(6) 2019.On (b)(6) 2018, the subject pacemaker was interrogated and all the content of the device memories was available.On (b)(6) 2019, during a follow-up, the heart rate curve, the lead measurements and the sleep apnea monitoring data were found missing from the device memories.

Event Description

Reportedly, the pacing system was implanted on (b)(6) 2019.On (b)(6) 2018, the subject pacemaker was interrogated and all the content of the device memories was available.On (b)(6) , during a follow-up, the heart rate curve, the lead measurements and the sleep apnea monitoring data were found missing from the device memories.

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: 9321285
• MDR Text Key: 177174386
• Report Number: 1000165971-2019-00631
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012735
• UDI-Public: (01)08031527012735(11)180412(17)191112
• 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: 03/16/2020

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: 11/12/2019
• Device Model Number: KORA 100 SR
• Device Catalogue Number: KORA 100 SR
• Device Lot Number: S0312
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1