MAUDE Adverse Event Report: MICROPORT CRM S.R.L. KORA 250 DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number KORA 250 DR

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880); Communication or Transmission Problem (2896)

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

At the regular follow-up on (b)(6) 2022, when the statistical data of aida was confirmed by interrogation, the bar graph of as-vs of the cardiac cycles distribution shook up and showed an abnormal display.Me (medical engineer) asked us to analyze why such an abnormal display was displayed.The patient has had pacemakers since their teens, and currently one pacemaker is in the left abdomen (manufactured by abbott) and one on the left anterior chest (manufactured by mp).An interrogation was conducted on (b)(6) 2022 to check the abbott pacemaker.Communication was interrupted when measuring the wave amplitude and threshold, and the measurement was forcibly terminated, so me suspected emi and removed the wand (programmer head) of the mp.After that, the check of the abbott pacemaker was finished successfully.Then, me checked the mp pacemaker, but found that the bar of the graph like the attached image was completely shaken.Pm: kora 250 dr (810be224) implanted on (b)(6) 2018 a: intermedics 432-35s-52 (324815) and v: intermedics 430-35s-58 (348981) implanted on (b)(6) 2003.

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

At the regular follow-up on (b)(6) 2022, when the statistical data of aida was confirmed by interrogation, the bar graph of as-vs of the cardiac cycles distribution shook up and showed an abnormal display.Me (medical engineer) asked us to analyze why such an abnormal display was displayed.The patient has had pacemakers since their teens, and currently one pacemaker is in the left abdomen (manufactured by abbott) and one on the left anterior chest (manufactured by mp).An interrogation was conducted on (b)(6) 2022 to check the abbott pacemaker.Communication was interrupted when measuring the wave amplitude and threshold, and the measurement was forcibly terminated, so me suspected emi and removed the wand (programmer head) of the mp.After that, the check of the abbott pacemaker was finished successfully.Then, me checked the mp pacemaker, but found that the bar of the graph like the attached image was completely shaken.

• Brand Name: KORA 250 DR
• 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
• MDR Report Key: 14953866
• MDR Text Key: 304354838
• Report Number: 1000165971-2022-00319
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

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
• Device Catalogue Number: KORA 250 DR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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