Model Number 3660ANS |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 09/25/2019 |
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.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported the patient was unable to establish a connection between the ipg and the patient controller (pc).Remote troubleshooting was unsuccessful in restoring access.The patient stated that it began after they underwent a surgical procedure and did not place the device into surgery mode.In turn, the patient may undergo surgical intervention as the next course of action.
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Manufacturer Narrative
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An inoperable pulse generator was reported to abbott.The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery was used.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.The results of the investigation are inconclusive since the device was not returned for analysis.Actions have been taken to prevent reoccurrence.
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Event Description
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It was reported that the patient underwent surgical intervention wherein the scs ipg was explanted and replaced to address the issue.Effective therapy was reportedly restored post-operatively.
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Manufacturer Narrative
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The reported issue ¿ipg would not connect to pc¿ was confirmed.The inability to communicate between the clinicians programmer and the implantable pulse generator was due to the device entering the service application state.This issue can occur when the device is exposed to an external energy source outside the device handling and storage requirements.Once the device has entered into the service application state, the cp will be inhibited from programming the device into the therapy application state.The report stated that the patient had an unrelated surgery.
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Search Alerts/Recalls
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