Model Number 106 |
Device Problem
Premature End-of-Life Indicator (1480)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/05/2019 |
Event Type
malfunction
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Event Description
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Initial report was that a physician was inquiring about whether or not the patient¿s device had prematurely depleted.The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process.Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths.Data from the patient's device was reviewed and it confirms that the battery depleted more quickly than expected.Clinic notes were received for the patient.Clinic notes indicated that the vns battery had dropped significantly since the patient¿s last office visit.No known surgical intervention has occurred to date.No other relevant information has been received to date.
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Event Description
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Patient underwent generator replacement surgery.The explanted generator was received by product analysis.Product analysis has not been completed to date.
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Manufacturer Narrative
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Corrected data, report no.1: device returned date inadvertently not included.
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Event Description
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Generator product analysis was completed.A visual assessment on the pcba, performed at the product analysis test bench, showed contaminates on the trimmed edge of the pcba (tab removed).No other visual anomalies were identified.The product analysis lab confirmed an ifi (intensified follow-up indicator)=no condition.Based on the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for both standby and pulsing modes of operation, and may have been the contributing factor for the reported allegation of premature end of life.
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Search Alerts/Recalls
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