Model Number 3183 |
Device Problems
Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Inadequate Pain Relief (2388)
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Event Date 02/20/2015 |
Event Type
Injury
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Event Description
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It was reported the patient experienced ineffective stimulation and a change in stimulation following a recent fall.It was also reported the patient no longer has stimulation in her right arm/elbow.It was also reported the patient has invalid impedance reading on multiple lead contacts.X-rays were taken and did not reveal any anomalies.Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2015 for a lead revision.However, during the procedure, the physician had difficulty repositioning the existing leads.As a result, the patient's leads were left in place.The patient may be referred for a paddle lead implant as the next course of action.
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Manufacturer Narrative
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(b)(4).Sjm 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.Sjm defers to the patient's physician regarding medical history.
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Manufacturer Narrative
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Sjm 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.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Follow-up information revealed the patient underwent surgical intervention where the patient's lead was explanted and replaced with a different model.The patient reported effective stimulation coverage postoperative and the issue is now resolved.
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Search Alerts/Recalls
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