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

Model Number KORA 250 DR

Device Problem Battery Problem: High Impedance (2947)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

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 microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, the subject pacemaker was interrogated in the box before the implant procedure on (b)(6) 2021; the battery impedance was 1.65 kohms.After lead connection, the battery impedance was 0.36 kohms.

Event Description

Reportedly, the subject pacemaker was interrogated in the box before the implant procedure on (b)(6) 2021; the battery impedance was 1.65 kohms.After lead connection, the battery impedance was 0.36 kohms.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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
• MDR Report Key: 11633121
• MDR Text Key: 244401227
• Report Number: 1000165971-2021-00388
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012919
• UDI-Public: (01)08031527012919(11)191008(17)211008
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2021
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Device Lot Number: S0428
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1