(b)(4).Additional suspect medical device component involved in the event: model#: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator.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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A report was received that during an exercise movement, the patient experienced an extreme sharp and sudden pain in his back.Since that time, the patient reported symptoms of tingling sensation in his hands and wrists, bottom of both feet and throughout both legs.The patient was also experiencing periodically blurring eye sight vision and weakness in hands, and stated that he had noticed dropping items from his hand from time to time.The physician does not know if the patient's symptoms are device related, and does not know the cause of the symptoms.The patient was scheduled to undergo a myelogram; ct scans of the cervical, thoracic and lumbar as well as a ct brain to rule out cerebrospinal fluid leak.The patient was also scheduled to undergo an electromyogram (emg) and nerve conduction test, but the patient passed away due to cardiac arrest.Therefore, these tests were never performed and no further information can be provided.
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