Model Number 3244 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Seizures (2063); Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 1 of 2: reference mfr report: 1627487-2017-07023.It was reported that the patient experienced ineffective therapy.In addition, the patient has a history of seizures and falls.As a result, surgical intervention may be pending to explant the patient¿s scs system.
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Event Description
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Device 1 of 2.Reference mfr report: 1627487-2017-07023.Follow up revealed that the patient elected to attempt to reprogram their device.The patient was upgraded to burst and will try out their new settings prior to making a decision whether surgical intervention is needed.
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Manufacturer Narrative
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Date of explant received.
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Event Description
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Additional information was received patient¿s system was explanted.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the devices were 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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