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Model Number 3389S-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Pain (1994); No Code Available (3191)
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Event Date 08/25/2017 |
Event Type
Injury
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: 3389s-40, lot# va1gkt7, implanted: (b)(6) 2017, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider about a patient with an implantable neurostimulator (ins) for dystonia and movement disorders.It was reported that the patient had a diagnosis of pneumocephalus on (b)(6) 2017.The event was stated to be related to the patient's implant procedure.The patient was seen during normal rounds and complained of the worst pain/headache they have ever experienced.At that time diagnostic imaging (x-ray, mri, ct scan etc) was performed and the pneumocephalus was discovered, with no other intracranial abnormality.The patient spent a couple extra days in the hospital for observation.A ct scan on (b)(6) 2017 showed that the pneumocephalus had resolved, and the patient had recovered without sequelae.No further complications were reported or anticipated.[refer to manufacturer report #2649622-2017-10193 for details pertaining to the reportable related event.].
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Manufacturer Narrative
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Weight updated.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received.It was reported that the pneumocephalus was thought to be related to the surgery and anesthesia, but the exact cause was not indicated.No further complications were reported/anticipated.
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Search Alerts/Recalls
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