Model Number SC-8216-50 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Edema (1820)
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Event Date 03/14/2017 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: model#: sc-8216-70 serial#: (b)(4) description: artisan surgical lead, 70cm it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
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Event Description
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A report was received that the patient had a fluid build-up at the implant site that was determined to be a cerebrospinal fluid leak.The physician believed that the cause was from a durotomy that occurred in the cervical spine during the scs implant.Patient underwent dural repair and fluid aspiration.The physician confirmed that the complication was not device related.The patient was doing well post-operatively.
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Manufacturer Narrative
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Additional information was received that the patient underwent an explant procedure wherein the ipg and leads were removed.No device malfunction was suspected.Additional suspect medical device component involved in the event: model#: sc-1132 serial #: (b)(4), description: precision spectra implantable pulse generator.The explanted devices were not returned to bsn as they were kept by the medical facility.
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Event Description
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A report was received that the patient had a fluid build-up at the implant site that was determined to be a cerebrospinal fluid leak.The physician believed that the cause was from a durotomy that occurred in the cervical spine during the scs implant.Patient underwent dural repair and fluid aspiration.The physician confirmed that the complication was not device related.The patient was doing well post-operatively.
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Search Alerts/Recalls
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