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Model Number 105 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
No Code Available (3191)
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Event Date 06/18/2015 |
Event Type
malfunction
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Event Description
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It was reported that during the patient's exploration surgery, electrocautery was used and may have touched the patient's generator, causing an asic latch-up condition, resulting in premature end of battery life.Pre-operative diagnostics yielded neos=no, but after the generator was re-positioned in the patient, diagnostics read neos=yes.The surgeon stated that he did not strike the generator with electrocautery.The generator was replaced.The explanted generator has been received by the manufacturer for analysis.However, analysis has not been completed to date.
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Event Description
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Analysis of the explanted generator was completed.Review of the data downloaded from the generator indicated that the pulse had been disabled by the generator.Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device explant, which may have been a contributing factor.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 3.139 volts as measured during completion of the final electrical test, shows an ifi=no condition.Other than the noted pulse disabled event, there were no additional performance or any other type of adverse condition found with the pulse generator.An fda medwatch 3500a form was received by the manufacturer from the user facility regarding this event, stating that the device did not perform as intended (uf/importer report # 3902560000-2015-8031).
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Search Alerts/Recalls
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