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Model Number 2200P-47E |
Device Problems
Bent (1059); Electrical /Electronic Property Problem (1198); Material Separation (1562); Device Inoperable (1663); Low impedance (2285); Device Displays Incorrect Message (2591); Material Deformation (2976)
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Patient Problems
Failure of Implant (1924); Therapeutic Response, Decreased (2271)
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Event Date 09/07/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device remains implanted.
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Event Description
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(b)(6) subject participating in the (b)(6) clinical trial (subject id (b)(6)), was originally implanted with a sham control device (sham neuroregulator) on (b)(6) 2011.This subject subsequently underwent conversion to the active maestro rechargeable system, with an active rechargeable neuroregulator, anterior lead and posterior lead implanted on (b)(6) 2013.On (b)(6) 2016, low impedance of the posterior lead was detected during a clinic visit.The associated alerts were cleared during the visit, but recurred within 24 hours.As a result, this subject is not receiving therapy from the device.
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Event Description
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An (b)(6) subject participating in the (b)(6) clinical trial (subject id (b)(6)), was originally implanted with a sham control device (sham neuroregulator) on (b)(6) 2011.This subject subsequently underwent conversion to the active maestro rechargeable system, with an active rechargeable neuroregulator, anterior lead and posterior lead implanted on (b)(6) 2013.On (b)(6) 2016, low impedance of the posterior lead was detected during a clinic visit.The associated alerts were cleared during the visit, but recurred within 24 hours.As a result, this subject is not receiving therapy from the device.Supplement 001: this subject underwent successful explant of the complete maestro rechargeable system on (b)(6) 2017.No adverse events were reported with the explant procedure.No explanted components have been received by enteromedics.
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Event Description
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An (b)(6) subject participating in the (b)(6) clinical trial (subject id (b)(6)), was originally implanted with a sham control device (sham neuroregulator) on (b)(6) 2011.This subject subsequently underwent conversion to the active maestro rechargeable system, with an active rechargeable neuroregulator, anterior lead and posterior lead implanted on (b)(6) 2013.On (b)(6) 2016, low impedance of the posterior lead was detected during a clinic visit.The associated alerts were cleared during the visit, but recurred within 24 hours.As a result, this subject is not receiving therapy from the device.Supplement 001: this subject underwent successful explant of the complete maestro rechargeable system on (b)(6) 2017.No adverse events were reported with the explant procedure.No explanted components have been received by enteromedics.Supplement 002: explanted device received for analysis on november 6, 2017.
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Search Alerts/Recalls
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