Model Number 3186 |
Device Problems
High impedance (1291); Therapy Delivered to Incorrect Body Area (1508)
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Patient Problems
Fall (1848); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
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Event Date 01/01/2015 |
Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627482-2015-05372.It was reported the patient has been receiving ineffective stimulation since experiencing a fall.Reprogramming to address the issue was unsuccessful due to stimulation being received in an unintended area.An impedance check revealed high impedance.As a result, the patient will undergo surgical intervention.
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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.(b)(4).
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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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Device 1 of 2.Reference mfr.Report#: 1627482-2015-05372.Follow-up revealed the patient's leads were explanted and replaced.Surgical intervention resolved the patient's issue.
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Search Alerts/Recalls
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