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Product id 8596, serial# (b)(4), implanted: (b)(6) 2006, product type: catheter.Udi# (b)(4).Product id 8596sc, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter, udi# (b)(4).If information is provided in the future, a supplemental report will be issued.
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Additional information was received from a healthcare provider (hcp) indicated the patient was (b)(6).Indication for use included transverse myelitis and cramp and spasm.The patient¿s medical history included transverse myelitis symptoms that began in 1998 with muscle spasms and numbness in bilateral lower extremities.As well as bilateral carpal tunnel syndrome.Right acl repair, orif right ankle, tubal ligation, lumpectomy right breast, and breast reduction.The pump was implanted in the late 1990s and has had three pumps including the current pump and the same catheter for 19 years.The patient was initially on oral baclofen and felt tired on what she felt was a high dose, but due to time lapse did not recall the exact dose.She had intrathecal baclofen initiated in the late 90s and was now on her third pump with brand baclofen.It was reported on (b)(6) 2019 the patient experienced suspected baclofen withdrawal and went to the emergency room (er).The patient¿s admitting diagnosis was pump failure with baclofen withdrawal.Her differential diagnosis was baclofen pump malfunction, transverse myelitis, and electrolyte abnormality.Withdrawal symptoms included spasms, vision changes, word finding difficulty, slow speech, vision and speech issues that continued through (b)(6) 2019.Medical notes from the er on (b)(6) 2019 and history of present illness indicated the patient presented with muscle spasms for the past week of her right lower extremity, worsening at night.The patient¿s husband reported that the spasms were so frequent that it had become debilitating and she was having trouble with her memory which had caused her to be very anxious and nervous.She had been taking 10mg oral baclofen without improvement of her spasms.She was not having any back pain, loss of control of her bowel or bladder.She had not had any fevers, chills, cough, diaphoresis, chest pain, or shortness of breath.The course in the er showed: 1100 consult: pump interrogation was suggested and patient not due for a refill until 2019-may-13, 1150: the patient was resting in her bed somnolent after norflex and opened her eyes to verbal stimuli, 1400: the patient was more awake and alert, still having some spasms.The company representative (rep) did an evaluation and interrogation, and the pump was working appropriately.1410: healthcare provider (hcp) did not think admission was necessary, would recommend 10-20 mg baclofen every 4 hours and would place an order for a dye study to evaluate the catheter.The medical notes showed medical decision making as follows: the patient came to the ed with one week of muscle spasms.The patient was stable on arrival and did have right lower extremity muscle spasms on exam and appeared anxious.The rep came to the ed and evaluated and did an interrogation of the pump which appeared to be working properly.It was unclear if there was a problem with the catheter at this time and the patient did improve with norflex in the ed.Admission was not warranted at this time and recommended dosing with 10-20 mg baclofen every 4 hrs as needed for muscle spasms.He would begin process of ordering a dye study to evaluate for catheter malfunction/disturbance.The patient was comfortable with this plan and was discharged in stable, non-toxic condition.The patient was referred for a dye study for an aging catheter on 2019-apr-17.On 2019-apr-17, recommended seeing a neurologist as symptoms not associated with withdrawal of baclofen.The pump was refilled on 2019-apr-17 and the logs and pump again interrogated without problems.The patient was seen on 2019-apr-17 at the rehabilitation center and the symptoms resolved without any change in pump setting.Telemetry read without any abnormal finding.It was noted it did not seem to be related to intrathecal baclofen at this time.An mri showed no new ms lesions and no acute event.Medical notes were provided from the rehabilitation center on (b)(6) 2019 and noted the patient had spasm, vision changes, loss of balance, and word finding and slowing of speech.The patient had not taken any oral baclofen since last friday (2019-apr-12) and was still experiencing vision and speech issues.Assessment indicated the pump was again interrogated without any problems recorded.The patient had less than 10 months left on the elective replacement indicator (eri).The current catheter was 19 years old and most likely working, but replacement may be warranted.The physician wanted to proceed with a dye study and try to get a new pump and catheter placed as soon as the six month replacement window happened, assuming the catheter would pass the dye study.The physician did not see ¿baclofen withdrawal¿ as part of her current symptoms.Of concern was her change in balance, speech and word finding.She felt her vision was not as it was prior to the incident last week.Review of systems on 2019-apr-17 showed decreased range of motion, weakness, muscle pain, joint pain (hip), and joint stiffness.Lower extremity numbness/tingling, loss of balance, and falls were also reported.The patient was also having a difficult time with finding words and using appropriate substitutions.Her speech pattern was slow.It was noted it seemed to be a neurological event, not associated with her history of transverse myelitis effecting her legs.A second event of transverse myelitis could be a possibility as could a non-motor neurological event.Seeing a neurologist in the physicians¿ opinion would be reasonable and prudent.The plan was a dye study request sent 2019-apr-12, pump and logs interrogated, patient was going to make an appointment with neurology for a referral, would start pump replacement to get in as early as possible and consider replacing an aging catheter.The patient¿s next exam date would be 2019-may-13 for a pump refill.Concomitant medications included: clonazepam 0.5mg1 by mouth (po) every night (qhs), hydrocodone acetaminophen 5/325 one po every 4-6 hours as needed, lyrica 150 mg capsule, trospium 20 mg one po twice a day (bid), losartan 25 mg one po every day.No further complications were reported or anticipated.
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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