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

Model Number KORA 250 DR

Device Problem Premature Discharge of Battery (1057)

Patient Problem Dizziness (2194)

Event Date 11/22/2022

Event Type  malfunction  

Event Description

During a follow-up visit, the device could not be interrogated.Magnet test was performed and the device did not seem to pace.The patient complained of dizziness.The device was explanted.

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 microport crm that was cleared or approved by fda for marketing in the united states.Preliminary analysis of the provided follow-up data revealed : the expected overall longevity is estimated at ¿ 116 months (9 years 6 months).The implantation duration was 68 months, which is lower than (b)(4) of the estimated overall longevity ((b)(4) of 116 months = 87 months).Based on hrs guidelines, premature battery depletion occurred.

Event Description

Reportedly, during a follow-up visit, the device could not be interrogated.Magnet test was performed and the device did not seem to pace.The patient complained of dizziness.The device was explanted.

Manufacturer Narrative

Complaint was re-opened following the reception of new data for analysis.Please refer to the updated attached analysis report.

Event Description

Reportedly, during a follow-up visit, the device could not be interrogated.Magnet test was performed and the device did not seem to pace.The patient complained of dizziness.The device was explanted.

• Brand Name: KORA
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 15985036
• MDR Text Key: 305522767
• Report Number: 1000165971-2022-00581
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023

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 Model Number: KORA 250 DR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/09/2023; 03/23/2023
• Supplement Dates FDA Received: 02/03/2023; 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Ethnicity: Non Hispanic