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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
Excess Flow or Over-Infusion (1311); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Bradycardia (1751); Dyspnea (1816); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Overdose (1988); Paralysis (1997); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Toxicity (2333); Numbness (2415); Ambulation Difficulties (2544); Peripheral Nervous Injury (4414); Paresthesia (4421); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 10/31/2019 |
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Event Type
Injury
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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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Information was received from a consumer regarding a patient receiving intrathecal bupivacaine 30,000 mcg/ml at 500 mcg/day and unknown morphine 30,000 mcg/ml at 100 mcg/day via an implanted pump.The patient was previously receiving intrathecal bupivacaine 20,000 mcg/ml at an unknown dose and unknown morphine 4,000 mcg/ml at an unknown dose.It was reported the pump was not working that great as it was not helping since 2020.It was noted the pump was working, but it was not strong enough.It was reported at each refill they had to increase it.On (b)(6) 2020, they increased her medication in the pump.It was further reported last night the patient laid in bed and her legs, from under her breast down, went numb.Then it came back.Today, in the last half an hour it was just numb.The patient reported she was paralyzed.She could not get up that well.It felt ¿like a stroke or something.¿ the patient thought it was because the medication in the pump was too strong.It was reported it was not a good feeling to be paralyzed and the patient was not able to get a hold of the healthcare provider (hcp).She tried calling the hcp but the office was closed already and she tried calling the company representative (rep) and left messages.The patient¿s daughter was on the way to take her to the hcp.The patient tried reading the dose and concentration from her print out and provided what the pump had before the refill and after the last refill.At one point, the patient reported ¿morphine was 5000.¿ it was also mentioned the patient used to have 5 boluses per day and now had 8 boluses per day.The patient was still on 30 some hours of lockout.Additional information was received from a manufacturer's representative (rep) via a healthcare provider (hcp) on 2020-oct-03 regarding a patient receiving intrathecal unknown morphine 5000 mcg/ml at 297 mcg/day and bupivacaine 30000 mcg/ml at 1700 mcg/day via an implantable infusion pump.The reason for call was suspected overinfusion of the pump.It was reported the patient was admitted to the hospital yesterday ((b)(6) 2020) experiencing "weakness in the legs" so the pump was turned down.There was no definitive diagnosis, so they checked the reservoir and hcp aspirated 21 ml when they were expecting 38 ml.It was noted the pump was last refilled about a week and a half ago.The pump had already been turned down on (b)(6) 2020 and then the patient presented on (b)(6) 2020 with increased weakness.On (b)(6) 2020, they also programmed the pump to minimum rate and emptied out the reservoir so there was currently nothing in it.It was reported they think the patient may have some bupivacaine toxicity.It was confirmed the pump was programmed to deliver 0.057 ml/day.The rep would follow-up with the hcp to inquire about possibility of a partial pocket fill at the time of the last refill or if they might have actually filled the pump with less than 40 mls, but programmed it as 40 mls.Additionally, it was reported on (b)(6) 2020, the patient was admitted to the intensive care unit (icu) for observation.They confirmed that a 40 ml syringe was used to fill the pump.The hcp had already cleared the catheter from the catheter access port (cap).No further complications were reported.
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Event Description
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On 2020-oct-07, additional information was received from the manufacturer representative (rep).Additional information reported the cause of the overinfusion/volume discrepancy and symptoms have not yet been determined.The patient's symptoms have resolved.The pump remained implanted, with explant tba.
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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.
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Manufacturer Narrative
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H3: evaluation of implantable pump serial number (b)(6) revealed that the pump exceeded the dispense accuracy specification by dispensing more fluid than the programmed rate during dispense accuracy testing in the lab.H6: the evaluation codes have been updated 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.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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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 received from a healthcare provider reported the patient had weakness on (b)(6) 2019.On (b)(6) 2019, there was a small open area at the posterior catheter incision site which was clean, dry, and intact not expressing fluid in appears to be very superficial.3 days later the patient presented to the clinic as they had a small open incision at the intrathecal catheter implantation site approximately 0.5 cm which was still clean, dry, and intact.On (b)(6) 2019, the patient had almost no pain symptoms but did still have weakness which only occurred when they provide their additional on demand doses.For this reason client agrees to escalate their simple continuous dosing to prialt 2 mcg per day with bupivacaine 5000 mcg per day and her ptm set to deliver 0.1 mcg of prialt q 3 hr max 4 doses per 24 hr.On (b)(6) 2019, the patient continued to have weakness.Client denied any adverse effects associated with targeted drug delivery system.Clients posterior lumbar incision site does have a small opening approximately 3 mm which is approximately 3-4 mm deep.There is no drainage.This area was attempted to be closed in clinic and appears to have open again.The client had no deep access to the intrathecal catheter pump site in the a small opening appears to be superficial in nature.The client will continue to evaluate but there is no need for surgical intervention at this time.On (b)(6) 2020, the patient had some numbness in the posterior buttocks region but no lower extremity weakness.The patient had weakness again on (b)(6) 2020.On (b)(6) 2020, the patient was experiencing weakness in the lower extremity presenting last friday and reduced 50%at hospital.The patient was doing better, but 48 hrs ago weakness again in lower extremity and difficulty standing/walking.Weakness does worsen with tdd bolus.50% reduction again today.On (b)(6) 2020, the patient had a new onset weakness in lower extremity without fcnv.Morphine and bupivacaine was reduced 50% at hospital.The patient transported home with 100% resolution of weakness symptoms.On (b)(6) 2020, the patient had ble flaccid weakness return.The patient was able to stand/walk with use of walls for support.Tdd again reduced 50% with resolution in 3-4 hours.On (b)(6) 2020, the patient woke up at 3am with significantly heavy legs and was hospitalized.The next day, the patient had flaccid ble paralysis and no pain.There was concern for lower motor neuron injury.No trauma, no obvious infection, and waxing/relapsing le weakness.Client had feeling that the flaccid weakness was ascending with described weakness in hands, but no difficulty breathing.Tdd turned to min rate.Ct/mris ordered.Consider spinal tap; neuro for gbs, tm, tdd med, etho vit def.No developing htn and bradycardia.No opioid wd symptoms.On (b)(6) 2020, the patient continued to have weakness t7 and below without improvement.The patient had bifrontal headache without cranial nerve deficits.More somnolent this am with bradycardia (40) and mean bp 63 (124 at admit).Cervical/lumbar mri w/o deficit.The patient had tingling in extremities.On (b)(6) 2020, the patient had local anesthetic excess and the it pump had normal programming but apparent excessive flow rate.Complete removal of it contents yesterday with beginning resolution of le weakness.Hypotension and bradycardia was improving and stable.The patient was moving their legs without problems but was still weak.A rij was placed for lipid emulsion but was not performed.The patient was a dmitted with paresthesia, generalized weakness, and pain pump problems.The patient had morphine/bupivacaine overdose,anesthetic toxicity, and weakness.The patient had been having intermittent episodes of paresthesia that will go from their feet all the way up to their breast level and then what frightened them last night is that they felt like it went up into their neck and they had difficulty breathing.Looking at records, the patient had this pain pump placed in (b)(6) 2019.Prior to that, it looks as though they had a pain stimulator in the past.The patient did admit to chronic back and neck pain.They report their medication was changed and they cannot tell me exactly when they think in the last month to morphine and bupivacaine.The patient reported ever since the medication change, and this was done because they were still having intractable pain with a previous medication, that they started to have these paresthesia.The hcp was aware and apparently did make changes to the amount of medication they were getting via the pump, but these symptoms still persisted, so much so that they reported they would have episodes that will last several hours.They seem to resolve without any intervention and then the patient reported they were able to move their legs slowly and that this will start to improve.Apparently when the patient was at carson valley medical center earlier this evening they reported they could not move.Now on presentation here as a direct admit the patient was able to move their legs and has sensation.The patient was in no respiratory distress.The patient was able to talk to me easy in full, long sentences as well.The patient denies any recent fall or trauma of note.The patient does have history remotely of a meningioma that they had treated with cyber knife.The patient's biggest concern though is that this feeling will return.The patient had laboratory work analysis at carson valley medical center that was fairly unremarkable.The patient also apparently was noted to be hypotensive during their stay, having systolic blood pressures in the 80s and diastolic in the 50s and 60sand was given fluid resuscitation.Her current blood pressure here is 148/88 with a pulse 76." the patient initially admitted to icu with concern for possible worsening anesthetic toxicity syndrome-lipid of motion was not needed as patient spontaneously began to improve symptoms with discontinuation of pain pump contents.The patient had hypertension upon admit at 154/109.The patient's wound to their anterior tibialis area had healing noted.No signs or symptoms of infection.On (b)(6) 2020, the patient had weakness in lower extremities.On 2 separate occasions the client was evaluated and their intrathecal bupivacaine and narcotic regimen was reduced by 50 percent with continued waxing and waning weakness in lower extremities.Client was then admitted to the hospital with a thoracic motor and sensory block.In-hospital client was evaluated with imaging studies as well as detailed investigation for the cause for their acute onset weakness which was determined to be intrathecal upon point which was running at too high of a rate.All interrogation of the pump indicated normal features.The medications in the pump were removed as well as the client was transferred to the intensive care unit for potential intra at lipid which was not required to be delivered with stabilization both cardiac function and resolution of lower extremity weakness.Client is now engaged with home care for physical therapy at home and ambulates in clinic today with a wheeled walker with recovery of their lower extremity strength deficits but with still stiffness and pain lower extremities.The patient decided to have the pump system explanted.The patient's pump was filled with 10 cc of normal saline.On (b)(6) 2020, the patient had paresthesia of skin due to malfunctioning pain pump.The pump was drained and was scheduled to be removed in a few weeks.The patient had a wound on the left side of their neck from a removed central line.The patient had not had parathesis since the pump was drained but had chronic pain.On (b)(6) 2020 the wound on the neck hadhealed.On (b)(6) 2020, the patient thinks they have a uti.The wound on neck healed.The line was inserted to treat the od symptoms associated with bupivacaine - the considered lipid infusion.The noted from (b)(6) 2020, noted the pain pump was malfunctioning.On (b)(6) 2020, the pump was providing too much medication in the hospital causing significant paralysis as well as cardiac hypotension and bradycardia treated by identifying that the pump with still active even though the programming indicated device was inactive by removing the intrathecal device medications.The patient had worsening muscle tone/strength and was waiting for explanation.On (b)(6) 2020, the patient had left foot drop.It was noted the patient had (b)(6) 2020, the pump and catheter were explanted.
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