MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D

Model Number PLATINIUM CRT-D 1711

Device Problem Pacing Intermittently (1443)

Patient Problems Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  Injury  

Event Description

During an intervention of left ventricular lead revision, the subject crt-d was programmed to doo prior to the procedure.The reporter used a medtronic plasmablade to prepare the pocket.Using the coag mode of the plasmablade, the platinium device reportedly inhibited stimulation despite being in doo mode.However, the device stimulated in cut mode as expected.

Manufacturer Narrative

Updated.

Event Description

During an intervention of left ventricular lead revision, the subject crt-d was programmed to doo prior to the procedure.The reporter used a medtronic plasmablade to prepare the pocket.Using the coag mode of the plasmablade, the platinium device reportedly inhibited stimulation despite being in doo mode.However, the device stimulated in cut mode as expected.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11716042
• MDR Text Key: 247018546
• Report Number: 1000165971-2021-00409
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014371
• UDI-Public: (01)08031527014371(11)160503(17)171203
• Combination Product (y/n): N
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2017
• Device Model Number: PLATINIUM CRT-D 1711
• Device Catalogue Number: PLATINIUM CRT-D 1711
• Device Lot Number: S0176
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention