Model Number 3186 |
Device Problems
High impedance (1291); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
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Event Date 04/13/2015 |
Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr.Report #1627487-2015-06200.It was reported the patient was experiencing ineffective and intermittent stimulation from his scs system.The patient also reportedly experienced stimulation in the wrong location.Additionally, the patient stated to have experienced a fall approximately 4-8 weeks ago.X-rays taken did not reveal any anomalies.An sjm representative met with the patient for system reprogramming and high lead impedances were noted.Effective stimulation was unable to be achieved through reprogramming.Surgical intervention is planned for a later date to address the issue.
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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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Event Description
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Device 1 of 2.Reference mfr.Report #1627487-2015-06200.Additional information received identified surgical intervention took place at which time the patient's scs leads were explanted and replaced.Effective stimulation was reportedly restored postoperative.
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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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Search Alerts/Recalls
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