MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA NEO 7 HF-T QP DF-1 IS4 PROMRI; CRT-D

Model Number	429552
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device was explanted due to inappropriate rapid atrial pacing.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Oral report as on april 2022: the returned device data have been inspected.During inspection of the available iegms the clinical observation could be confirmed.The iegms of episode number 2, 3 and 4 showed device stimulation at the programmed maximum cls rate.The episodes occurred at 5:41am and 7:04am on (b)(6) and (b)(6) 2022, respectively.The available follow-up records showed that the device was programmed to ddd-cls at the time of occurrence of the above mentioned episodes.Cls was used with a maximum cls rate of 130 bpm and a resting rate control of +20bpm.Please note, that the device is equipped with an acceleration sensor, which is used to detect and evaluate changes in movement.The cls algorithm is designed to increase the pacing rate above the resting threshold (base rate + resting rate control) only when the motion persists longer than an internally defined motion timer.On the other hand, resting is detected only when the resting period lasts longer than another internally defined timer, named resting timer.This implementation is intended to avoid premature rate adjustments in the event of short-lasting periods of either movement, including simple postural changes, or rest.Based on the available data the motion pattern during the above mentioned episodes cannot be reconstructed.However, all cls parameters were inspected extensively and found to be normal and as expected.The available device data showed no indication of a device malfunction.Results of product analysis after receipt of icd on july 2022: the device was received and analyzed.Incoming interrogation revealed the battery status bos.A number of three charging cycles was documented.The memory content of the icd was inspected, showing a normal device function while implanted and in service.The icd was subjected to an electrical analysis.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached.In conclusion, the device proved to be fully functional.The analysis of the memory content showed a normal device behavior while the device was implanted and in service.All cls parameters were inspected extensively and found to be normal and as expected.The available device data showed no indication of a device malfunction.

• Brand Name: INTICA NEO 7 HF-T QP DF-1 IS4 PROMRI
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14976737
• Report Number: 1028232-2022-03476
• Device Sequence Number: 17411577
• Product Code: NIK
• UDI-Device Identifier: 04035479156824
• UDI-Public: (01)04035479156824(17)230430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 429552
• Device Catalogue Number: 429552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male