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

Model Number PLATINIUM SONR CRT-D 1841

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/11/2020

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

Event Description

The patient undergoes regular therapies.Reportedly, the remote reports dated 11 december 2020 and 17 december 2020 showed atp therapy deliveries on (b)(6) 2020 and (b)(6) 2020, respectively.However, no alert was transmitted to the physician.In addition, the atp therapy delivered on (b)(6) 2020 was not recorded in the episodes and therapies overview of the remote report dated 11 december 2020.Two atp therapies were indicated in the episodes and therapies overview of the remote report dated 17 december 2020; however, only one episode was available in the remote report.The patient had experienced unsuccessful patient initiated transmissions (pit) in the past.Preliminary analysis revealed that no alert was transmitted to the physician for the atp therapy deliveries dated (b)(6) 2020 and (b)(6) 2020 because the maximum number of alert transmissions for atp therapy delivery between two in-clinic follow-ups was reached.The first atp therapy episode dated (b)(6) 2020 was erased according to episode recording management specifications.

Event Description

The patient undergoes regular therapies.Reportedly, the remote reports dated (b)(6) 2020 showed atp therapy deliveries on (b)(6) 2020, respectively.However, no alert was transmitted to the physician.In addition, the atp therapy delivered on (b)(6) 2020 was not recorded in the episodes and therapies overview of the remote report dated (b)(6) 2020.Two atp therapies were indicated in the episodes and therapies overview of the remote report dated (b)(6) 2020; however, only one episode was available in the remote report.The patient had experienced unsuccessful patient initiated transmissions (pit) in the past.Preliminary analysis revealed that no alert was transmitted to the physician for the atp therapy deliveries dated (b)(6) 2020 because the maximum number of alert transmissions for atp therapy delivery between two in-clinic follow-ups was reached.The first atp therapy episode dated (b)(6) 2020 was erased according to episode recording management specifications.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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: 11176163
• MDR Text Key: 251104774
• Report Number: 1000165971-2021-00222
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014425
• UDI-Public: (01)08031527014425(11)151023(17)170523
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2017
• Device Model Number: PLATINIUM SONR CRT-D 1841
• Device Catalogue Number: PLATINIUM SONR CRT-D 1841
• Device Lot Number: S0124
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/24/2020
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1