Model Number 381462 |
Device Problem
Premature End-of-Life Indicator (1480)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that the clinic received a message via homemonitoring that the icd shows the eos status.The patient was hospitalized.
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Manufacturer Narrative
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Device was explanted on (b)(6) 2023.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were reviewed.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.The icd interrogation revealed the eos battery status, detected on (b)(6) 2023, confirming the clinical observation.The device was implanted for 118 months.An amount of 47 charging cycles was documented.The memory content of the icd was inspected, revealing a normal current consumption of this device.However, the amount of charge taken from the battery was verified and the battery condition was not as expected.Therefore, the icd was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.In a next step, the electronic module was attached to an external power supply and the eos status was removed with a technical programmer to check the functionality of the electronic module.The overall measured current consumption was normal and as expected.Analysis of the electronic module revealed no indication of a malfunction.Therefore, the battery was sent to the manufacturer for further analysis.The battery analysis is currently ongoing.As soon as the analysis is completed, this report will be updated.
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Manufacturer Narrative
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Device was explanted on: (b)(6) 2023.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were reviewed.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.The icd interrogation revealed the eos battery status, detected on august 22, 2023, confirming the clinical observation.The device was implanted for 118 months.An amount of 47 charging cycles was documented.The memory content of the icd was inspected, revealing a normal current consumption of this device.However, the amount of charge taken from the battery was verified and the battery condition was not as expected.Therefore, the icd was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.In a next step, the electronic module was attached to an external power supply and the eos status was removed with a technical programmer to check the functionality of the electronic module.The overall measured current consumption was normal and as expected.Analysis of the electronic module revealed no indication of a malfunction.Therefore, the battery was sent to the manufacturer for further analysis.The manufacturing records of the battery were inspected, documenting that the battery parameters were within specification during the battery manufacturing.No anomalies were documented during the production process associated with this battery.The visual inspection of the battery did not reveal any external signs of damage.In a next step, the battery was opened for destructive analysis.During the analysis of the inner assembly an elevated internal battery impedance was identified.It is reasonable to assume that the increased impedance has led to a voltage drop and therefore to the clinical observation.In conclusion, analysis of the devices electronic module showed no indication of a malfunction.Further investigations revealed an elevated battery impedance as the root cause of the clinical observation.
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Search Alerts/Recalls
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