Model Number 3662 |
Device Problems
Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 05/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 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 that diagnostics indicated the patient's ipg went into service app mode following an unrelated surgery in which surgery mode was not activated.Surgical intervention may take place to explant and replace the ipg.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further patient information was requested but not received.
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Event Description
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It was reported during follow up that the patient underwent surgical intervention during which the patient's ipg was explanted and replaced.Surgery addressed the issue.
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Search Alerts/Recalls
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