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

Model Number	429527
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was explanted due to shock impedance being too low (less than 20 ohms) approx.88 months after the implantation.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The icd and the lead under complaint were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of these devices as well as on the returned icd data.The manufacturing processes for the icd and the lead were re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance tests proved the devices functions to be as specified.The returned data have been analyzed.During inspection of the available iegm of episode 197, the clinical observation could be confirmed.The iegm showed a regular detected vf episode with one documented charging cycle of the high voltage capacitors.The charging cycle was aborted, as expected, due to the detection of an external short circuit, which might have otherwise damaged the icd.There was no indication of an icd malfunction.Further analysis revealed the presence of noise in the ff channel.No other anomalies were noted.In conclusion, the devices were not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.Noise was observed in the ff channel.However, based on the information available for analysis the root cause was not determinable.A damage of the lead cannot be excluded.

• Brand Name: ILIVIA NEO 7 HF-T QP DF-1 IS4 PROMRI
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14349731
• Report Number: 1028232-2022-02405
• Device Sequence Number: 14682856
• Product Code: NIK
• UDI-Device Identifier: 04035479156725
• UDI-Public: 04035479156725
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 02/28/2021
• Device Model Number: 429527
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• 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 Sex: Unknown