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

Model Number	429529
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This device shows eri with unexpected battery behavior.Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
(b)(6) 2024 device explanted.
Additional Manufacturer Narrative
On (b)(6) 2024 device explanted.Upon receipt, the device was interrogated, confirming the device status eri.The icd was implanted for 9 months and 7 charging cycles were recorded in the devices memory.The memory content of the device was inspected.The inspection revealed, that the icd activated the eri status, because during an automatic signature check the device detected invalid memory content in the live-holter, a memory range containing battery data.In general, the icd is equipped with the ability to detect and repair invalid memory content.If there was invalid memory content found in the live-holter, by design the icd will activate the device status eri to avoid an incorrect automatic longevity calculation.Furthermore, 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 and the charging time was normal and as expected.In conclusion, the clinical observation resulted from invalid memory content in the live-holter.The invalid memory content was automatically detected by the device leading to the activation of the eri status.The ability of the device to deliver therapies is not affected by this safety mechanism.

• Brand Name: ILIVIA NEO 7 DR-T DF-1 PROMRI
• Common Device Name: 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: 18446550
• Report Number: 1028232-2024-00041
• Device Sequence Number: 20748314
• Product Code: MRM
• UDI-Device Identifier: 04035479156749
• UDI-Public: (01)04035479156749(17)241231
• 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: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2024

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: 12/31/2024
• Device Model Number: 429529
• Device Catalogue Number: 429529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 01/18/2024; 10/09/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 01/22/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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: 70 YR
• Patient Sex: Male