Model Number 3660 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 07/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.
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Event Description
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It was reported that the patient cannot connect to their ipg.The patient underwent a surgical procedure in which they did not use surgery mode.The patient may undergo surgical intervention to replace their ipg.
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Manufacturer Narrative
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An inoperable implant was reported to abbott.The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used.The implant was not returned for analysis.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Based on the information received, the cause of the reported incident is consistent with user error.
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Event Description
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It was reported that the patient had their ipg replaced on 8/21.Therapy was established post op.
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Search Alerts/Recalls
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