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

Model Number PLATINIUM SONR CRT-D 1811

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Atrial Fibrillation (1729)

Event Date 05/28/2021

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, a warning message stating that the defibrillation system may be ineffective was displayed after delivering two shocks through the programmer to treat an atrial fibrillation.The shocks were delivered with an energy of 0.0 joules.All other device parameters were within normal range.No anomaly was observed during the standard follow-ups performed before and after the cardioversion.Preliminary analysis confirmed ineffective high-energy eps shock deliveries on 18 may 2021 due to overload conditions.Recommendations to evaluate the benefit of crt-d replacement were provided on 16 june 2021 as a hardware issue could not be excluded.

Manufacturer Narrative

Microport crm was notified on (b)(6) 2021 that a re-intervention was performed.The crt-d and ventricular lead were explanted and discarded.Please refer to the attached analysis report.

Event Description

Reportedly, a warning message stating that the defibrillation system may be ineffective was displayed after delivering two shocks through the programmer to treat an atrial fibrillation.The shocks were delivered with an energy of 0.0 joules.All other device parameters were within normal range.No anomaly was observed during the standard follow-ups performed before and after the cardioversion.Preliminary analysis confirmed ineffective high-energy eps shock deliveries on (b)(6) 2021 due to overload conditions.Recommendations to evaluate the benefit of crt-d replacement were provided on (b)(6) 2021 as a hardware issue could not be excluded.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 12050697
• MDR Text Key: 257785380
• Report Number: 1000165971-2021-00507
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(11)190211(17)200911
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

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: 09/11/2020
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: PLATINIUM SONR CRT-D 1811
• Device Lot Number: S0352
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1