MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA NEO 7 DR-T DF-1 PROMRI; ICD

Model Number 429529

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2022

Event Type  malfunction  

Event Description

This icd was implanted and explanted in the same day due to possible issues with the header and the rv lead connection.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Manufacturer Narrative

Upon receipt, the icd was interrogated, revealing the battery status bos.The memory content of the device was inspected, revealing no anomalies.The header of the icd was inspected, revealing no anomalies.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.The set screws showed screw marks on the bottom side indicating that they were tightened during the implantation.All dimensions of the header bores were within the range.Also the spring elements of the device did not show any deviations.In a next step, 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 normal and expected sensing and shock delivery.In particular, the specified energy level was reached.Furthermore, the manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.In conclusion, there was no indication of a device malfunction.

• Brand Name: ILIVIA NEO 7 DR-T DF-1 PROMRI
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14136780
• MDR Text Key: 289456335
• Report Number: 1028232-2022-01971
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 04035479156749
• UDI-Public: (01)04035479156749(17)231031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 429529
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male