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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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| Model Number 8637-40 |
| Device Problems
Insufficient Flow or Under Infusion (2182); Protective Measures Problem (3015)
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| Patient Problems
Muscle Spasm(s) (1966); Muscular Rigidity (1968); Pain (1994); Therapeutic Effects, Unexpected (2099)
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| Event Date 11/07/2016 |
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 8784, serial#: (b)(4), implanted: (b)(6) 2016, product type: catheter.Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2015, product type: catheter.Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 18-may-2017, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: 17-nov-2016, udi#: (b)(4).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 initially received from a consumer (friend/family member of patient) regarding a patient who was currently receiving lioresal of unknown concentration at a dose rate of 900 mcg/day via an implantable pump for cerebrovascular accident (cva) das system and intractable spasticity.It was reported on (b)(6) 2019 that at the patient¿s last pump refill which occurred last week in (b)(6) 2019, the patient notified their physician that she had a lot of spasticity and was having to take oral baclofen because of it.They took her dose up to 900 mcg.Now after the refill the patient¿s spasticity seems worse.The patient has had to take oral baclofen 3-4 times a day, which the reporter indicated was extreme.It was noted that the physician mentioned at the appointment that it could be that the pump wasn't working properly.It was unknown if the change in symptoms/therapy occurred suddenly or gradually.It was further reported that the patient had fell and the pump had seemed out of position which occurred a month and a half ago or more (day, month, and year unknown), but when they looked at it they told her it seemed to be ok.Regarding the patient¿s spasticity, the issue was described as having been ongoing; date of event including day, month, and year were unknown.The patient had called the physician¿s office on (b)(6) 2019 but there was no answer.The reporter was inquiring if there was anyone available in their area that could check her pump to see if it was operating properly.At the time of the report an email was sent to a company representative to call the reporter.On (b)(6) 2019, a company representative indicated that they had returned his phone call.Additional information was received from a consumer via a company representative on (b)(6) 2019.It was noted that the company representative was able to contact the patient regarding their pump having been checked.It was further noted that an alternate company representative had seen the patient in the emergency room (er) who had read the pump.The pump was read and was determined to be functioning normally.Regarding actions taken to resolve the worsening spasticity, it was noted that the patient was going to transfer their care to an alternate physician.The spasticity had not been resolved.The patient¿s weight at the time of the event was unknown.Regarding the current status of the device, it was indicated that the pump was still implanted.The information was clarified as having been confirmed with the physician/account.Additional information was later received from a consumer (friend/family member of patient) on (b)(6) 2019.The patient's advocate indicated that they saw a company representative who confirmed that the motor was running in the pump.It was further noted however that the catheter had maybe pulled out because it was not delivering medication.It was noted that the issues were centered around the patient getting worse with spasms, a fall, and the pump possibly not delivering medication.The patient was taking oral baclofen but had not been able to schedule a dye test because they physician had not returned their calls.The reporter inquired if they should go to the emergency room with the patient.It was reviewed at the time of the report that if it was medically necessary, the patient could consider going to the er to help with the symptoms presented at that given time.Physician listings were sent.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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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 on 12-jun-2019 from a healthcare professional (hcp) who reported he had been doing interventional spine for 33 years, had placed over 2000 pumps, and was currently managing 200-300 active pumps.Per the hcp, this patient was a post-stroke syndrome patient (post cva) and her device was placed by another physician.Per the hcp, the patient and her significant other came to him as they didn¿t think that her prior physician was doing what was right for her and wasn¿t helping her.The hcp stated that out of practice he did not take other physician's pumps because you are at a disadvantage, and without placing the device there are a lot of things he didn't know about the device, catheter placement and everything else.He stated that as he always did, he reviewed the patient and her imaging, visualized the pump and catheter, and had a clinical specialist evaluate the pump.He stated that the clinical specialist told him everything was fine with the pump.He stated that the patient never felt like she was achieving significant relief from the device.She came to them with a 2000 mcg concentration and she was somewhere around 900 mcg infusion.He stated that over time, probably the last two years, every time they did a refill they would check residual volumes.Her residual volume never changed and was always within normal limits or within expected volume.He stated she had an abdominal pump.He stated that he made it a practice in the past to do diagnostics, catheter studies and rotor studies.What he learned from those studies was that unless you had something wrong with the residual volumes, normally symptom problems were due to the underlying pathology and not the system.He stated he stopped doing rotor studies and myelograms.He stated that the patient's symptom pattern fluctuated up and down.They would do increases and at one point she got up to 1000 mcg.She would get some degree of relief and then her symptoms would worsen.He stated that at one point she overdosed on oral medications, was admitted to a local hospital, and the hospitalist contacted him requesting that the pump be interrogated.He stated the hospitalist thought that perhaps as well as opioids the patient had a problem with baclofen or baclofen was contributing.A clinical specialist was sent and interrogated pump.He stated that infusion was reduced per the hospitalist's recommendation.He stated that the patient eventually was discharged and came back to him.The reduced infusion caused worsening symptoms.The patient came and they interrogated the pump and checked the volume and it was as was predicted.There was no indication of over infusion or under infusion, the residual volume was exactly what was predicted.Because the patient¿s symptoms got worse from the reduction they did an increase and over time they managed doing increases.The hcp stated the patient was a complicated patient with a number of orthopedic issues, had a knee replacement or knee surgery.A number of her symptom complaints were not only the upper motor neuron pathology, the central pain pattern from the stroke.They checked volumes but did not do any catheter diagnostics because he thought what was happening was related to the disease process.No further complications were reported/anticipated.
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Manufacturer Narrative
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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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Event Description
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Additional information was received on (b)(6) 2019 from (b)(6) who provided additional information from the patient¿s cur rent pump managing physician.No further treatments had been rendered as of (b)(6) 2019.Pump telemetry on (b)(6) 2019 was noted to be normal.Per clinic notes dated (b)(6) 2019, the patient¿s vital signs were stable.The current baclofen dose was 876.2 mcg/day.Symptom level 0-10 was a 10 described as muscle spasms.The patient was taken to the pain clinic procedural area.The pump was accessed and refilled with 40 ml of baclofen at 2600 mcg/ml.Complex programming by her request increasing her basal rate of baclofen from 876 to 900 mcg/day.Alarm values were reset.It was noted that with respect to the device, things seemed to be going okay.The patient was complaining about increased muscle spasms but that had been a common denominator through time.She was requesting oral baclofen to take in combination with the spinal infusion, but the physician denied the patient¿s request based on what occurred the prior time the patient was given oral baclofen (10 mg tid).They discussed infusion pump increases and the patient was told that 1000 mcg would be the ceiling.There would be no further increases once she hit that point.The patient had no other symptom pattern changes, no change in medical history, and no new medical diagnosis.There were no other surgeries planned or proposed in any body region.The patient¿s concomitant medications had included lipitor, dantrium, lisinopril, amlodipine, baclofen, seroquel, dulcolax, prilosec, flexeril, cymbalta, stool softener, and methadone.No further complications were reported/anticipated.
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Event Description
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Additional information was received on 05-jul-2019 from saol therapeutics who provided additional information from the patient¿s cur rent pump managing physician.Per the physician, his initial evaluation of the patient occurred on (b)(6) 2017.The patient¿s prior pump managing physician had provided him with a number of different documentations which he reviewed.When he reviewed the docume ntation he also reviewed an x-ray which the patient presented which identified the pump and spinal catheter.The tip of the spinal catheter appeared to be at t12, although it was difficult to fully evaluate because of the quality of the image.Her pump was in the lower abdominal quadrant.According to the patient and her significant other, she had a history of a post-stroke central pain patterns characterized as intractable upper and lower extremity spasms.The patient and her significant other were not satisfied with the care she was receiving from her prior pump managing physician.When she presented, the pump was infusing baclofen at 600 mcg/day in flex mode.The physician stated that he agreed to take the patient as there did not appear to be anywhere else for her to go.She was requesting that he manage her refills.At that time, he told her that he would refill the pump, but if the device required any other interventions or revision, it would be difficult since he was not the implanter.Her symptom pattern was described as fairly intense spasms in the upper and lower extremities.These spasms appeared constant although they were more troublesome at night.This was verified/confirmed by reviewing the documentation from the prior physician¿s dictation dated (b)(6) 2016.The dictation also included that the patient had told her prior physician that she was incredibly angry with the physician for not understanding her pain after which the prior physician suggested to the patient and her significant other that they find someone else to manage her pump.Per the current pump managing physician, it was obvious from the patient¿s prior pump managing physician¿s notes and documentation that the baclofen infusion device was poorly effective in managing the patient¿s symptoms since the patient continued to have intense spasms throughout that treatment period of time.Based on the documentation, the patient¿s symptoms were essentially unchanged.The current pump managing physician had performed a series of refills with the first being (b)(6) 2017.At that time her basal rate of baclofen was increased to 663 mcg/day.The refill on (b)(6) 2017 was considered her baseline.For subsequent refills there was no appreciable or significant difference between the predicted and actual volumes.The refill dates provided noted: (b)(6) 2017 (almost identical), (b)(6) 2017 (1.3 ml), (b)(6) 2017 (0.8 ml), (b)(6) 2017 (1.4 ml), (b)(6) 2017 (0.8 ml) and (b)(6) 2018 (0.6 ml), (b)(6) 2018 (1.2 ml), (b)(6) 2018 (1.8 ml), and on (b)(6) 2018 (1.2 ml).During these periods of treatment evaluations, it was noted that the patient continued to have intense spasms, like those initially identified by her prior physician¿s notations.It was also noted in the prior physician¿s notes, simultaneous orthopedic and musculoskeletal contributing pain patterns.It was shown that she had a rotator cuff injury which was assumed to be the right shoulder comment pattern of her pain and a left lower extremity component also felt to be orthopedic focused into the knee.There was a history of a postlaminectomy at l4-5 factor contributing to her lumbar lower back components.Per the physician, ¿it would therefore, seem consistent, that the sum total of her postcentral stroke condition along with orthopedic, musculoskeletal and nervous system components all contributed to her pain pattern and spasms, which were poorly controlled¿.Through a series of evaluations, refills, and reprogramming they had adjusted her baclofen dose at one point close to 1000 mcg/day which was considered the upper safe limit.There was never a point at which they felt they were adequately controlling her symptom pattern.She continued to have symptoms just as was noted by her prior pump managing physician.Her symptoms seemed to wax and wane almost cyclically through time, although they continued to be the same problem.It never appeared that they were adequately gaining control of this pattern of spasms and pain.At one point, they even performed a spinal cord stimulator trial ((b)(6) 2017) in an attempt to help some of her lower extremity and back components.Ultimately, she had knee surgery which took her to rehab.During that period of time she began having increasing amounts of spasms.The patient had also had multiple hospitalizations.During the hospitalizations, they were called to evaluate the device¿s functionality.At each time, the device was shown to be fully functional.During one of the hospitalizations she presented to the emergency room completely obtunded, apparently overdosing on medications.During her infusion therapy with their clinic, they added hydromorphone to assist with some of her symptoms which were felt to be contributing by way of orthopedic, musculoskeletal injuries, and spinal injuries.Referring back to the prior physician¿s notes, it appeared that the best pain control the patient ever achieved was when she had a combination of baclofen spinally along with oral methadone.The hydromorphone they included in the infusion was eventually discontinued after a hospitalization for overdose.The patient openly admitted to them that she fell an average of 2-4 times per week which this physician felt would certainly contribute to her overall degree of pain and musculoskeletal spasms.On (b)(6) 2019 the patient presented to their office suggesting that after a number of slips and falls that she felt like her device was not functioning properly.The physician examined the device in her lower abdominal quadrant and found it to be intact.There were no indications of swelling, seroma formation, or bruising.He also ordered and x-ray which was reviewed.Although somewhat difficult to fully evaluate, the device was found to be in the appropriate location, consistent with baseline.He could visualize the catheter as it moved away from the pump towards the spine entering the spine, ¿although unfortunately because the catheter is radiopaque, it could not be visualized within the spine¿.He concluded by this that it appeared everything was in the appropriate location based on the x-ray.This, in combination with appropriate correlation between the actual and residual volumes, was suggesting that the device was still intact and functioning properly.In this physician¿s opinion, the intense spasms were a reflection of her central pain pattern and syndrome aggravated and irritated by a number of falls, multiple fractures, including her cervical spine as well as the surgery to her knee and lower extremity.At the patient¿s emergency room visit on (b)(6) 2019 there were no stalls or other abnormalities noted which suggested that the pump was functioning properly.During this time, she was having increased spasms.It was suggested that a catheter dye study be performed; however, it was the physician¿s opinion that a catheter dye study for a patient with an abdominally implanted pump was difficult.It was his recommendation that if a dye study was to be done, then it would need to be done intraoperatively in surgery with the possibility of removing or replacing the catheter and the pump possibly.The physician felt this would have a number of inherent risks with respect to this patient and her medical history.The physician stated again that in his opinion that more than likely the increasing amount of pain was not a pump or catheter problem or malfunction but rather an exacerbation of the underlying pain condition and her other musculoskeletal components.
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Manufacturer Narrative
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H6 ¿ corrected information: method code 4114 is not applicable for this event.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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