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 Battery Problem (2885)

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

After an implantation period of approx.8 months, an unexpected decrease of the remaining battery charge was observed.No adverse patient events were reported.Device currently remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

Device was received for evaluation.Explant date is currently unknown.Upon receipt, the device interrogation revealed the eri battery status, one charging cycle was documented to the devices memory.The device was subjected to an electrical analysis.The amount of charge taken from the battery was verified and proven to be consistent with the eri battery status.The current consumption of the icd was measured and found to be elevated.Next, 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.In a next step the icd was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.Further electrical investigations revealed that an integrated circuit of the electronic module was damaged, causing an elevated current consumption, draining the battery.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, an elevated current consumption due to a damaged integrated circuit was identified to be the root cause for the clinical observation.The manufacturing records document a normal device production.It is therefore assumed that the high current condition occurred after the device shipment, however the date of occurrence was not determinable.All therapy functions of the icd were available while the device was implanted and in service.

• 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: 16686610
• MDR Text Key: 312759315
• Report Number: 1028232-2023-01737
• 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: 07/17/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 429567
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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