Model Number SC-1112 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Nausea (1970); Complaint, Ill-Defined (2331); Patient Problem/Medical Problem (2688)
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Event Date 06/06/2018 |
Event Type
Injury
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Event Description
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A report was received that the patient underwent two separate implant procedures.The patient underwent a lead implant procedure and then an ipg implant procedure.After the ipg implant procedure, the patient developed a migraine-like headache and nausea, which was moderate in severity.The patient was treated with medication and the event was resolved.The physician noted that the issue was related to the surgical procedure and not related to the device system.
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Event Description
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A report was received that the patient underwent two separate implant procedures.The patient underwent a lead implant procedure and then an ipg implant procedure.After the ipg implant procedure, the patient developed a migraine-like headache and nausea, which was moderate in severity.The patient was treated with medication and the event was resolved.The physician noted that the issue was related to the surgical procedure and not related to the device system.
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Manufacturer Narrative
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A review of the manufacturing documentation for the sc-1112 (serial number: (b)(4)) revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
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Event Description
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A report was received that the patient underwent two separate implant procedures.The patient underwent a lead implant procedure and then an ipg implant procedure.After the ipg implant procedure, the patient developed a migraine-like headache and nausea, which was moderate in severity.The patient was treated with medication and the event was resolved.The physician noted that the issue was related to the surgical procedure and not related to the device system.
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Manufacturer Narrative
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Additional information was received that the patient developed migraine-like headache and nausea, which was mild in severity.The physician assessed that the event was not related to the device system.
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Event Description
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A report was received that the patient underwent two separate implant procedures.The patient underwent a lead implant procedure and then an ipg implant procedure.After the ipg implant procedure, the patient developed a migraine-like headache and nausea, which was moderate in severity.The patient was treated with medication and the event was resolved.The physician noted that the issue was related to the surgical procedure and not related to the device system.
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Manufacturer Narrative
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Additional information was received that the event was related to the device system.Amendment: adverse event/product problem.
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Event Description
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A report was received that the patient underwent two separate implant procedures.The patient underwent a lead implant procedure and then an ipg implant procedure.After the ipg implant procedure, the patient developed a migraine-like headache and nausea, which was moderate in severity.The patient was treated with medication and the event was resolved.The physician noted that the issue was related to the surgical procedure and not related to the device system.
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Search Alerts/Recalls
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