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

Model Number PLATINIUM 4LV SONR CRT-D 1844

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

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 sorin that was cleared or approved by fda for marketing in the united states.

Event Description

On (b)(6) 2017, the defibrillation system was implanted.Reportedly, during a follow-up on (b)(6) 2020, a shock therapy was observed on (b)(6) 2020.According to the physician, the shock is suspected to be inappropriate, as the patient was in an atrial fibrillation during almost the whole day.The clinical record of the patient was reviewed because vvi mode at 40 min-1 was programmed for an unknown reason.Reportedly the patient¿s condition worsened after the implantation, with a qrs length of 158 ms, which was longer with pacing than without pacing.It was also observed that no markers were recorded in the device memories for the shock nor for the atp therapy.Only the markers for the charges were observed.

Event Description

On (b)(6) 2017, the defibrillation system was implanted.Reportedly, during a follow-up on (b)(6) 2020, a shock therapy was observed on (b)(6) 2020.According to the physician, the shock is suspected to be inappropriate, as the patient was in an atrial fibrillation during almost the whole day.The clinical record of the patient was reviewed because vvi mode at 40 min-1 was programmed for an unknown reason.Reportedly the patient's condition worsened after the implantation, with a qrs length of 158 ms, which was longer with pacing than without pacing.It was also observed that no markers were recorded in the device memories for the shock nor for the atp therapy.Only the markers for the charges were observed.

• 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: 11141528
• MDR Text Key: 227486128
• Report Number: 1000165971-2021-00214
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014524
• UDI-Public: (01)08031527014524(11)170612(17)190112
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2019
• Device Model Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Catalogue Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Lot Number: S0267
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/14/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1