Model Number 106 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 04/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluated by mfr? no, device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
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Event Description
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It was reported that the patient underwent generator and lead explant due to infection and extrusion.Additional information was received that the patient had a infection about 6 weeks after first implant.Patient underwent surgery to clean and flush the area and was provided with antibiotics.About 4 weeks after this surgery, the devices were removed via another surgery due to the wound opening and the generator and lead coming up under the skin.A review of device history records showed that both the lead and generator were sterilized prior to distribution.
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Event Description
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Explanted generator and lead were received.Potential contributing factors to allergic reaction and infection were evaluated and none were found to exist in this situation.The device history record shows that the pulse generator passed all specifications before it was released.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse condition found with the pulse generator.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.
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Search Alerts/Recalls
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