MAUDE Adverse Event Report: MICROPORT CRM S.R.L. SONR; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number SONRTIP PS55D

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Event Description

Reportedly, the patient came to regular fu to site on (b)(6) 2024, had an echo examination prior to crt-d-fu.Patient has "bad heart performance/results".Fcs was interested what the sonr signal or sonr aida data would say and if it would be "consistant" with the echo examination.But no sonr data could be seen: missing blue bars for g-values of the sonr lead for the last 6 months.Also the av & vv delay were fixed to one value over the 6 months with no variation at all.Also the presumed measured avd were the same with 102ms and 133ms over the 6 months monitoring period.Av and vv sonr optimization are programmed.Initial limitation due to af was seen as plausible answer but the patient was not in af for the whole last 6 months.Also in theory af would at least allow for vv optimization if no av due to af can be measured.

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.

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.The subject sonrtip lead is connected to the atrial channel of the active implantable device platinium sonr crt-d 1811 sn (b)(6).The subject sonrtip lead was implanted on (b)(6) 2013 and it was connected to the device the platinium sonr crt-d 1811 sn (b)(6) on (b)(6) 2019.The review of provided data highlighted the reported issue: lack of sonr signal amplitude in aida and fixed values of the vv and av delay.The analysis also highlighted decreases in both the atrial impedance measurement and the atrial amplitudes.Since (b)(6) 2022, vv and av delay haven¿t been reprogrammed through sonr optimization: - the patient was having atrial arrhythmia (no optimization during atrial arrhythmia), - or the sonr amplitude was too low to allow the sonr optimization, - or when the sonr optimization occurred, there was no change in the optimization measurements compared to previous measurements, therefore no change in vv and/or av delays.Sonr amplitude can be displayed in the sonr optimization screen when it is higher than 0,1 g.The atrial impedance and the atrial amplitude are slowly decreasing since (b)(6) 2022.Since the subject sonrtip has not been explanted, and therefore returned, no further investigation can be conducted.This case is retained and utilized for trend purposes.

Event Description

Reportedly, the patient came to regular fu to site on (b)(6) 2024, had an echo examination prior to crt-d-fu.Patient has "bad heart performance/results".Fcs was interested what the sonr signal or sonr aida data would say and if it would be "consistant" with the echo examination.But no sonr data could be seen: missing blue bars for g-values of the sonr lead for the last 6 months.Also the av & vv delay were fixed to one value over the 6 months with no variation at all.Also the presumed measured avd were the same with 102ms and 133ms over the 6 months monitoring period.Av and vv sonr optimization are programmed.Initial limitation due to af was seen as plausible answer but the patient was not in af for the whole last 6 months.Also in theory af would at least allow for vv optimization if no av due to af can be measured.

• Brand Name: SONR
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• 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: 18986319
• MDR Text Key: 338760815
• Report Number: 1000165971-2024-00280
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2016
• Device Model Number: SONRTIP PS55D
• Device Catalogue Number: TLD0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2013
• 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