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

Model Number KORA 100 DR

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr 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

The subject pacemaker was implanted on (b)(6) 2015.Premature battery depletion was reported.The pacemaker was replaced on (b)(6) 2020.

Event Description

The subject pacemaker was implanted on (b)(6) 2015.Premature battery depletion was reported.The pacemaker was replaced on (b)(6) 2020.

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: 11321315
• MDR Text Key: 233740140
• Report Number: 1000165971-2021-00285
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012711
• UDI-Public: (01)08031527012711(11)150818(17)170318
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2017
• Device Model Number: KORA 100 DR
• Device Catalogue Number: KORA 100 DR
• Device Lot Number: S0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2021
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1