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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
Filling Problem (1233); Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Excessive Heating (4030)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331); Electric Shock (2554)
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| Event Date 12/05/2018 |
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Event Type
malfunction
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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 lioresal (concentration and dose unknown) via an implanted pump for intractable spasticity.It was reported the patient¿s pump was ¿exceedingly hot¿ most of the time.It was noted there was nothing on the skin surface, no redness and she was not running a fever.The sensation was only at the pump site.The patient was currently experiencing the sensation.It was reported she felt it for the last three weeks and it was almost constant.About 2 ½ weeks ago it felt like ¿electric shocks or stabbing¿ around the pump.The patient told her healthcare provider (hcp) about this and the hcp thought it could be adhesions and scar tissue.It was further reported it "never quite seemed right from the beginning" with her current pump.It was reported the patient ¿falls a lot¿ and she had fallen four times in one week, but she had not landed directly on the pump.It was mentioned at the patient¿s first fill in (b)(6) 2019 the hcp had a very hard time finding the port and the pump did not ¿flip¿ but it ¿turned completely around¿ and does move inside of her body.The event date was three weeks ago regarding the heating sensation.It was noted the hcp talked about a dye test but one had not been done yet.No further complications were reported.
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Manufacturer Narrative
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Product id 8709, serial# (b)(4), implanted: (b)(6) 2006, product type: catheter.Other relevant device(s) are: product id: 8709, serial #: (b)(4), ubd: 2008-11-09, 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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Additional information was received via a healthcare provider.It was reported that a dye study performed on (b)(6) 2019 showed a partial obstruction of her intrathecal catheter.The patient had experienced increased pain, had an uncomfortable feeling, and a few episodes of electric shock.The patient¿s weight was described as (b)(6).Regarding the current status of the affected device, it was noted that the patient was referred to a neurosurgeon to discuss the obstructed catheter.Additional information was also received via (b)(4) on (b)(6) 2019.(b)(4) had contacted a healthcare provider for additional information.The patient¿s race was provided.The patient¿s height was 65 inches and their weight was (b)(6).The patient¿s medical history included the following: hypercholesterolemia, degenerative spine disease, hyperreflexia, hypertension (htn), chronic active epstein¿barr virus infections from ventriculoperitoneal shunt (vps), coronary artery disease (cad), and lumbar fusion.Concomitant medications included the following: preservision, metoprolol, generlac, vitamin d3, acetylsalicylic acid (asa), fiorinal, pantoprazole, cartia, atorvastatin, tylenol extra strength (es), and valium.The patient initially started lioresal in ¿1997?¿ (unclear as reported).The concentration of lioresal was 1,000 mg/ml.Regarding the lot number and expiration date of lioresal the following was noted: 04112019 + 549043; expiration date 2019-may-01.The indication for use regarding lioresal was hyperreflexia and hyperspasticity.Regarding resolution/date of resolution of the patient not having woke up for 10 hours from the anesthetic following pump implantation on (b)(6) 2018, it was noted that this was unknown and was not done by their office.Regarding felt like electric shocks or stabbing around the pump, it was noted that on (b)(6) 2019 the patient complained of difficulties since the pump was replaced.Regarding the pump site described as exceedingly hot, it was noted that at a (b)(6) appointment the patient stated getting really hot about 4 to 6 weeks ago.It was further reported that on (b)(6) 2019 nuclear medicine spinal infusion pump study finding suggested a partial obstruction of the intrathecal pump catheter.It was noted as being unknown if the patient was admitted / hospitalized subsequent to these events.
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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 from a healthcare provider (hcp) indicated the cause of the heating sensation from the pump was not determined.It was noted the patient did not experience any symptoms related to the heating sensation coming from the pump.Overall, the hcp had checked the pump readings and there were no alarms, the logs were checked, and no inconsistencies.It was noted the refill was appropriate.The patient¿s weight at the time of the event was (b)(6)pounds and the pump was currently implanted.No further complications were reported/anticipated or expected.
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Event Description
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Additional information as received from a healthcare provider and consumer via a company representative.The company representative had a conversation with a neurosurgeon, pa that was managing and filling the pump, and patient.It was further indicated that the patient was now saying that the heating of the battery had went away.The battery heating up and causing shocking sensation was no longer occurring.The patient had a recent dose increase that was helping.The patient was having fewer falls or episodes of spasticity.Because of this, the neurosurgeon and managing pa had decided to provide conservative measures of just increasing the dosing if necessary.No catheter revision was planned at this time.No surgical intervention had occurred or was scheduled.The issue was noted as having been resolved at the time of the report.The patient was without injury regarding their status at the time of the report.The patient thought that the heating may have been due to a urinary tract infection (uti) she had.It was further noted however that environmental/external/patient factors that may have led or contributed to the issue, were unknown.The pump was noted as having administered compounded baclofen with concentration 1100 mcg/ml.The dose rate was approximately 250 mcg/day at an unknown dose rate.On (b)(6) 2019 a healthcare provider reported that the location of the partially obstructed catheter was unknown.The cause of the partially obstructed catheter was not determined.The patient had a recent dose increase which was helping.No interventions were planned at this time; just conservative measures.Regarding the cause of the previous report of the pump turned completely around /was moving inside the patient¿s body, it was noted that the cause was not determined.The pump appeared to be stable in the pocket.No actions were taken regarding the pump turned around / moving.The cause/circumstances that led to the pump heating and shocking sensation was unknown.It was noted that the patient thought it might have been due to a urinary tract infection.The pump turning around/moving, heating sensation, shocking sensation, increased pain, and discomfort had been resolved.However, it remained unknown if the issue regarding the obstructed catheter was resolved.The patient¿s recent dose increase was helping so they wanted to see how things play out and increase the dose again if needed.Regarding the current status of the device, it was noted that they were still implanted.
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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.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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