Model Number SC-1132 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Complaint, Ill-Defined (2331); Inadequate Pain Relief (2388); Patient Problem/Medical Problem (2688); No Code Available (3191)
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Event Date 06/27/2019 |
Event Type
Injury
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Event Description
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A report was received that the patient experienced a burning pain when stimulation was on or off and she was dissatisfied with the stimulation.The patient underwent an ipg explant procedure.
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Manufacturer Narrative
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The returned ipg was analyzed, passed all required tests performed and exhibited normal device characteristics.The complaint was not confirmed.
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Event Description
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A report was received that the patient experienced a burning pain when stimulation was on or off and she was dissatisfied with the stimulation.The patient underwent an ipg explant procedure.
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Manufacturer Narrative
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Additional information was received that the physician assessed the patient never felt pain relief and implied the patient may have psychological issues that could have impacted the pain outcomes.The patient is doing well postoperatively.
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Event Description
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A report was received that the patient experienced a burning pain when stimulation was on or off and she was dissatisfied with the stimulation.The patient underwent an ipg explant procedure.
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Search Alerts/Recalls
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