MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number PLATINIUM DR 1510

Device Problem Over-Sensing (1438)

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

Event Date 04/05/2024

Event Type  malfunction  

Manufacturer Narrative

The review of provided data confirmed the reported issue and highlighted icd lead issue.The subject device is a dual chamber device, implanted on (b)(6) 2021, for box replacement.The leads are leads from other manufacturers on 26 october 2010.The icd lead and the subject device are df-1 connection.780 sustained fast vt/vf episodes without therapy delivery have been recorded since (b)(6) 2024.Inappropriate charges occur during all these episodes.Ventricular oversensing is suspected.The analysis of the file of (b)(6) 2024 revealed high impedance and coil continuities, low ventricular amplitudes and ventricular oversensing of non-physiological signal.All these abnormal elements appeared since (b)(6) 2024.The data before (b)(6) 2024 show normal device-lead functioning.Icd lead issue is highly suspected.The decrease of the time to rrt from 10-15 years in (b)(6) 2023 to 3-5 years in (b)(6) 2024 is due to the numerous sustained vf episodes that have been recorded and that have forced the device to charge the capacitors (no shock delivery).Battery curve analysis is ongoing.No general malfunction is suspected on the subject device.This case is retained and utilized for trend purposes.

Event Description

Reportedly, on (b)(6) 2024, during a scheduled follow-up of platinium dr 1510 (b)(6), the device had unstable svc/rv coil and pacing lead impedances: the doctor requested to analyze the data to determine if there are any malfunction in the product.One year ago, the battery longevity was 10-15 years, but now it is 3-5 years at the day.The abnormal value was recognized for the first time at this follow-up on (b)(6) 2024 after the replacement in 2021.It was confirmed that there was no abnormal lead impedance at the previous follow-up as well.At the time of replacement of the icd on (b)(6) 2021, the currently implanted ventricular lead (a competitor¿s product) could not be removed from the previous icd (paradym), so the lead was removed by destroying the previous icd body, and the ventricular lead continued to be used and was connected to the icd (platinium s/n: (b)(6) ).The patient wonders if this is what led to the current malfunction.The request is for data analysis only, and analysis is difficult since there are no leads, but the manufacturer's opinion is requested.Both leads (atrial/ventricular) are competitor¿s products and implanted on (b)(6) 2010.The data after replacement will be provided during the next week.

• Brand Name: PLATINIUM
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 ; 146013665
• MDR Report Key: 19162838
• MDR Text Key: 341687653
• Report Number: 1000165971-2024-00342
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 08031527015378
• UDI-Public: (01)08031527015378(17)231223(11)230621
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2023
• Device Model Number: PLATINIUM DR 1510
• Device Catalogue Number: TDF032J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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