Model Number NMD0006 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 07/01/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient had lost therapy.As a result, the patient underwent surgical intervention during which the system was explanted and replaced with another manufacturer's system.It was noted that the lead was naturally worn during the procedure.
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Manufacturer Narrative
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Date of event is estimated.Date of implant is unknown.The unique device identifier (udi) is not provided because the device is unknown.Initial reporter phone number: (b)(6).
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Manufacturer Narrative
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A patient having ineffective stimulation was reported to abbott.The patient's lead was replaced and effective stimulation was restored.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 event could not be conclusively determined.
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Search Alerts/Recalls
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