Model Number 103 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/06/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the patient's generator was showing 25% battery status indicator when check on (b)(6) 2015.The device was recently implanted on (b)(6) 2015.The patient had burr hole surgery (on her brain) on (b)(6) 2015.The company representative programmed the device off prior to the surgery, and everything was reportedly okay with the patient's vns (battery status and impedance).It was noted that electrocautery was used during the burr hole surgery.It was reported that the electrocautery did not directly strike the device, but depending on the location/proximity of the grounding pad, it may have likely made some contact.No known surgical intervention has occurred to date.No additional relevant information has been received to date.Mfr report # 1644487-2015-05676 captures a report of high impedance with this generator.
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Event Description
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The patient had generator replacement on (b)(6) 2015.Lead impedance was okay pre-operatively and post-operatively.Pre-operatively, the battery status was ifi-yes.The generator will not be returned for analysis per hospital policy.Additional programming and diagnostic data was assessed.From (b)(6) 2015 (burr hole surgery date) and (b)(6) 2015.There was no evidence of premature battery depletion on these dates.No additional relevant information has been received to date.Mfg report # 1644487-2015-05676 captures a report of high impedance with this generator.
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Event Description
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Additional programming/diagnostic data was reviewed for the patient's device.There was an interrogation and system diagnostic test performed on (b)(6) 2015.Lead impedance was within normal limits (1932 ohms and 2008 ohms).The battery status dropped to 25%, which occurred when the battery capacity passed 7.5% consumed.No additional relevant information has been received to date.
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Event Description
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Operatives notes from the (b)(6) 2015 surgery were received.There was no mention of the type of fashion that the chest was opened during surgery on that date (e.G.Cautery, etc.), so this did not provide any information that may have been able to clarify the sudden drop in battery voltage after the surgery.
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Search Alerts/Recalls
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