Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Cramp(s) (2193)
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Event Type
Injury
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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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Event Description
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It was reported the patient experienced painful stimulation at the lead site (described by the patient as burning sensation).Programming was able to resolved the issue at the time, however, the patient experienced pain and cramping on the right side of her body later.As a result, the patient will undergo surgical intervention.
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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 revealed the lead was repositioned on (b)(6) 2016.The patient received effective stimulation following the procedure.
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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 revealed the patient did not have any further complaints on burning at the lead site.The patient did still have mild postoperative pain/discomfort.The doctor informed the patient it could take a few months to improve.
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Search Alerts/Recalls
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