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

Model Number PLATINIUM SONR CRT-D 1811

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Tachycardia (2095)

Event Date 08/28/2023

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

Reportedly, 2 shocks were delivered in (b)(6) 2023.For the first shock no energy (0j) was delivered.The second shock was delivered with 31j and shock impedance at 139 ohms.The coil continuity impedance is stable and in normal range.

Manufacturer Narrative

Correction of g3 field to : healthcare representative review of the provided data revealed : - on (b)(6) 2023, during a tachycardia episode 2 shocks were launched by the device.O the first shock was not delivered due to an overload measurement.O less than one second later, the second shock delivered 31j with a high impedance measurement.The shock was partially delivered.- since (b)(6) 2023, right ventricular lead impedance measurements were stable and within normal range.The device was explanted and returned for analysis : - upon reception, the returned device was interrogated: o 2 small holes were observed on the can of the device.These holes were probably created by a degraded lead in contact with the device.O ventricular channel was with 2,6 v amplitude, and 0.63ms pacing pulse width; o proper sensing and pacing operations were observed; o no overconsumption was observed during consumption measurements by telemetry.O battery voltage was measured at 2,97v.O low energy shock between the rv coil and the case could not be properly delivered by the device.Investigation revealed damage of the integrated circuit (ic), at the level of the circuits driving the shock delivery.- based on the aforementioned observations, the most probable hypothesis to explain the device impossibility to properly deliver the 1st shock is a temporary short circuit (created by a temporary contact with a degraded lead).Performing this 1st shock attempt in these conditions, lead to permanent damage on the diamond ic of the device and consequently the 2nd shock could not be totally delivered.

Event Description

Reportedly, 2 shocks were delivered in (b)(6) 2023.For the first shock no energy (0j) was delivered.The second shock was delivered with 31j and shock impedance at 139 ohms.The coil continuity impedance is stable and in normal range.

• 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: 17799004
• MDR Text Key: 324041752
• Report Number: 1000165971-2023-00761
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

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 SONR CRT-D 1811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/27/2023
• 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