MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number PLATINIUM 4LV SONR CRT-D 1844

Device Problem Connection Problem (2900)

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

Event Date 09/20/2023

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

Suspected defect of the right atrial connector: repeatedly high impedance values after insertion and screwing the right atrial lead into its connector.This lead showed ¿normal¿ impedance values when inserted into psa analyzer.All found during the implant procedure.

Manufacturer Narrative

The conclusions are as follows: - the electrical characteristics of the returned device conformed to established specifications.Upon reception of the device, pacing pulses were generated appropriately by the device.- the visual inspection did not reveal any abnormality.The analysis confirms that the connection system of the subject pacemaker functioned as specified using a duplicate torque-limiting screwdriver.- no abnormality has been found and the lead connection test was successful.- the issue described in the complaint could not be reproduced.- based on the available information and the information provided in the complaint description, a lead issue could not be excluded.- the complaint is recorded for trending purposes.For more details, please refer to the attached analysis report.

Event Description

Suspected defect of the right atrial connector: repeatedly high impedance values after insertion and screwing the right atrial lead into its connector.This lead showed ¿normal¿ impedance values when inserted into psa analyzer.All found during the implant procedure.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 17977493
• MDR Text Key: 326176949
• Report Number: 1000165971-2023-00861
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 12/13/2023

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: PLATINIUM 4LV SONR CRT-D 1844
• Device Catalogue Number: PLATINIUM 4LV SONR CRT-D 1844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/13/2023
• 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