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Model Number 2200A-47E |
Device Problems
Electrical /Electronic Property Problem (1198); High impedance (1291); Device Inoperable (1663); Device Displays Incorrect Message (2591)
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Patient Problems
Adhesion(s) (1695); Failure of Implant (1924); Therapeutic Response, Decreased (2271)
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Event Date 11/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device remains implanted; not returned.
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Event Description
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(b)(6) subject participating in the (b)(6) clinical trial was implanted with the maestro rechargeable system on (b)(6) 2011.During a clinic visit on (b)(6) 2016, it was determined that a short circuit of the anterior lead had been experienced on (b)(6) 2016 and an anterior lead open circuit was experienced on (b)(6) 2016.This subject first reported a flashing red light on the mobile charger during the clinic visit on (b)(6) 2016.During this visit, alarms were noted for low rnr battery, the anterior tip to ring short circuit, and the anterior lead open circuit.Therapy was re-started at this visit, and alarms were cleared.Red light was reported by subject to have returned on (b)(6) 2016.During an additional clinic visit on (b)(6) 2016, alarm code 3 (impedance high) was encountered.Diagnostic evaluation reported by the site included another anterior lead tip to ring open circuit on (b)(6) 2016.
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Event Description
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(b)(6) subject participating in (b)(6) was implanted with the maestro rechargeable system on (b)(6) 2011.During a clinic visit on (b)(6) 2016, it was determined that a short circuit of the anterior lead had been experienced on (b)(6) 2016 and an anterior lead open circuit was experienced on (b)(6) 2016.This subject first reported a flashing red light on the mobile charger during the clinic visit on (b)(6) 2016.During this visit, alarms were noted for low rnr battery, the anterior tip to ring short circuit, and the anterior lead open circuit.Therapy was re-started at this visit, and alarms were cleared.Red light was reported by subject to have returned on (b)(6) 2016.During an additional clinic visit on (b)(6) 2016, alarm code 3 (impedance high) was encountered.Diagnostic evaluation reported by the site included another anterior lead tip to ring open circuit on (b)(6) 2016.Update: device was explanted on (b)(6) 2016.Extensive adhesions were noted during the explant.The entire maestro rechargeable system was removed.
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Search Alerts/Recalls
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