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

Model Number PLATINIUM 4LV CRT-D 1744

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

Reportedly, the initial longevity calculate in the app is larger than the real longevity.

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

Reportedly, the initial longevity calculate in the app is larger than the real longevity.

Manufacturer Narrative

The device was explanted on (b)(6) 2023 and then the device was discarded.

Manufacturer Narrative

Analysis of the available data revealed : the battery voltage was measured at 2.67v on (b)(6) 2023 and time to rrt estimated to < 3 months.The device was implanted on (b)(7) 2018 and was explanted on (b)(6) 2023 no overconsumption was measured based on available data, the expected overall longevity is estimated at ¿ 104 months (8 years 7 months).The implantation duration was 62 months, which is lower than 75% of the estimated overall longevity (75% of 104 months = 78 months).Based on hrs guidelines, premature battery depletion occurred.The subject device was released according to applicable standard operating procedures.Because the device was not returned for analysis, no further investigations can be performed.The root cause could not be determined.

Event Description

Reportedly, the device was explanted about 5 years after the implantation.It is less than expected (indicated in the longevity simulator : longevityfit).

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRON
• 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: 17451298
• MDR Text Key: 320315949
• Report Number: 1000165971-2023-00580
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLATINIUM 4LV CRT-D 1744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• 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