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

Model Number	PLATINIUM CRT-D 1741
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2021 that the patient complained of occasional symptomatic light headedness.Interrogating the crt-d revealed several mode switch episodes with absence of true atrial arrhythmia.The patient had a history of minor atrial oversensing that was previously managed by decreasing the atrial sensitivity; however, the stored episodes seen on (b)(6) 2021 revealed more oversensing that before.Provocative testing was performed and the noise on the atrial channel was reproduced along with ventricular oversensing when the patient was lying on the back, with the head turning from side to side.The noise was not reproduced via isometrics, valsalva maneuvers, deep respiration or coughing.Post-v and post-r refractory periods were set to 155ms and the ventricular sensitivity was reprogrammed to 0.8mv.Following these adjustments, further ventricular oversensing was unable to be reproduced and the impact on the inappropriate mode switch will be monitored over time.Evaluation of the position and performance of the leads, especially the atrial lead will be scheduled.

• Brand Name: PLATINIUM
• Common Device Name: 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: 11630960
• Report Number: 1000165971-2021-00386
• Device Sequence Number: 14369447
• Product Code: NIK
• UDI-Device Identifier: 08031527015484
• UDI-Public: (01)08031527015484(11)170529(17)191129
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2019
• Device Model Number: PLATINIUM CRT-D 1741
• Device Catalogue Number: PLATINIUM CRT-D 1741
• Device Lot Number: S0289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention