MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA NEO 5 HF-T DF-1 IS-1 PROMRI; NO MATCH

Model Number 429567

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem Arrhythmia (1721)

Event Date 01/27/2023

Event Type  Injury  

Event Description

Patient had an electrical storm which depleted the device battery, causing it to go eos.Device remains implanted and patient is scheduled for an ablation.There is no indication that the device malfunctioned.Should additional information be received, this file will be updated.

Manufacturer Narrative

The icd was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The returned device data have been analyzed.The analysis did not show any anomalies.The battery status eos was activated by the icd on (b)(6) 2023 due to a large amount of charging cycles with shock deliveries within less than an hour.The available iegms revealed that the detected episodes resulted exclusively from intrinsic heart signals and were properly detected and treated by the icd.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of a device malfunction.

• Brand Name: INTICA NEO 5 HF-T DF-1 IS-1 PROMRI
• Type of Device: NO MATCH
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16292406
• MDR Text Key: 308730915
• Report Number: 1028232-2023-00579
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 429567
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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