Model Number 2200A-47E |
Device Problems
Failure to Conduct (1114); Disconnection (1171); Electrical /Electronic Property Problem (1198); High impedance (1291); Device Inoperable (1663); Device Displays Incorrect Message (2591); Material Distortion (2977); Material Twisted/Bent (2981)
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Patient Problems
Failure of Implant (1924); Therapeutic Response, Decreased (2271)
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Event Date 12/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device still implanted; not returned.
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Event Description
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This subject is a participant in the (b)(6) clinical trial.This subject was originally in the control arm of the trial and underwent implantation of the active maestro rechargeable system on (b)(6) 2014.Subject noticed a flashing red light that was reported on (b)(6) 2016.During a clinic visit on (b)(6) 2016, it was reported that the subject has an open circuit of the implanted anterior lead.Therapy is not being delivered.
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Manufacturer Narrative
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Device not yet returned.
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Event Description
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This subject is a participant in the recharge clinical trial.This subject was originally in the control arm of the trial and underwent implantation of the active maestro rechargeable system on (b)(6) 2014.Subject noticed a flashing red light that was reported on (b)(6) 2016.During a clinic visit on (b)(6) 2016, it was reported that the subject has an open circuit of the implanted anterior lead.Therapy is not being delivered.Supplement 001: subject underwent revision of the maestro rechargeable system on (b)(6) 2017.Because the anterior lead was twisted with the posterior lead, all device components were replaced.Revision procedure was successfully completed without adverse impact to subject.Explanted device components have not yet been received by enteromedics.Reference mdr 3005025697-2017-00014 for report related to the posterior lead.
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Event Description
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This subject is a participant in the recharge clinical trial.This subject was originally in the control arm of the trial and underwent implantation of the active maestro rechargeable system on (b)(6) 2014.Subject noticed a flashing red light that was reported on (b)(6) 2016.During a clinic visit on (b)(6) 2016, it was reported that the subject has an open circuit of the implanted anterior lead.Therapy is not being delivered.Supplement 001: subject underwent revision of the maestro rechargeable system on (b)(6) 2017.Because the anterior lead was twisted with the posterior lead, all device components were replaced.Revision procedure was successfully completed without adverse impact to subject.Explanted device components have not yet been received by enteromedics.Reference mdr 3005025697-2017-00014 for report related to the posterior lead.Supplement 002: explanted device components received on (b)(6) 2017.
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Search Alerts/Recalls
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