Model Number 429522 |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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The device was not returned for analysis.The analysis is therefore only based on the returned device data as well as the inspection of the quality documents associated with the manufacture of this particular device.The manufacturing process for this device was reviewed.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing.In particular, the final acceptance test proved the device functions to be as specified.In a next step, the returned device data was inspected.During the inspection the clinical observation could be confirmed.Analysis revealed an unexpected battery behavior, which led to the clinical observation.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component, which may compromise the ability of the device to deliver therapy.Biotronik has informed the health care professional about this analysis result, who decides, based on the patients individual circumstances and medical judgment, if the device will be exchanged.Should further relevant information or the device itself become available, this investigation will be updated and you will be informed accordingly.
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Manufacturer Narrative
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Device explanted (b)(6) 2024.The device was not returned for analysis.The analysis is therefore only based on the returned device data as well as the inspection of the quality documents associated with the manufacture of this particular device.The manufacturing process for this device was reviewed.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing.In particular, the final acceptance test proved the device functions to be as specified.In a next step, the returned device data was inspected.During the inspection the clinical observation could be confirmed.Analysis revealed an unexpected battery behavior, which led to the clinical observation.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component, which may compromise the ability of the device to deliver therapy.Biotronik has informed the health care professional about this analysis result, who decides, based on the patients individual circumstances and medical judgment, if the device will be exchanged.Should further relevant information or the device itself become available, this investigation will be updated and you will be informed accordingly.
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Search Alerts/Recalls
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