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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); Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423)
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| Patient Problems
Bradycardia (1751); Cardiac Arrest (1762); Fatigue (1849); Hypothermia (1915); Hypoventilation (1916); Itching Sensation (1943); Muscular Rigidity (1968); Pain (1994); Seroma (2069); Discomfort (2330); Ventilator Dependent (2395); Loss of consciousness (2418); Irritability (2421); Sleep Dysfunction (2517); Cognitive Changes (2551); Lethargy (2560)
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| Event Date 08/01/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2008, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 14-jul-2010, 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 received from the healthcare provider (hcp) via a device manufacturer representative regarding a patient receiving baclofen (2000 mcg/ml at 1000 mcg/day) via an implantable infusion pump.It was reported that the patient was scheduled to have a refill on monday however the hcp was having difficulties accessing the pump and was not able to refill so they rescheduled the refill for yesterday (b)(6) 2020.The pump was refilled and the hcp used fluoro to make sure they were in the pump.It was noted that everything seemed fine initially however a couple hours later the patient's mom reported that the patient was unresponsive.By the time they got to the emergency room the patient was completely non-responsive.They had to perform cpr and the patient was in cardiac arrest.The caller reported that the patient was currently in the icu and being monitored.It was stated that at the patient's previous refill was in (b)(6) 2020 and they ran across a similar issue where they had difficulty with the refill and after the refill the patient ended up going to the er for displays of overdose and withdrawal symptoms.The patient's dose was lowered at that time and then they had withdrawal symptoms after.They are thinking the issue might be related to kinking/coiling of the catheter.The caller reported they have a replacement scheduled on (b)(6) 2020.
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Event Description
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Additional information received from a healthcare provider via a drug partner reported the patient had their pump refilled, on (b)(6) 2020, and went into overdose resulting in the patient being in the icu on respiratory support.The patient had altered mental status after the previous refill back in (b)(6).The physician's assistant suspected pump malfunction and had spoken with manufacture representative.The pa mentioned that the patient had been very difficult to refill and that the refill had to be done with ultrasound guidance.It was noted after the refill, the patient was lethargic and drowsy.The patient was bradycardic before they had cardiac arrest.The dose was decreased by 90% and was supplemented with oral baclofen.The patient had prolonged qtc and other testing, mostly neurologic.
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Manufacturer Narrative
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Continuation of d10: product id: 8709sc, lot# serial# (b)(6), implanted: (b)(6) 2008, explanted: product type: catheter.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 from a healthcare professional (hcp) via a company representative who reported that the pump was replaced, and the surgeon thought the pump and catheter were fine and that a possible pocket fill occurred.
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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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Manufacturer Narrative
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H3: evaluation of implantable pump serial number (b)(6) revealed no significant anomalies.Destructive analysis identified wear on the motor o-ring for gear number three, however, the wear did not affect the performance of the device during testing in the lab.The returned pump passed all functional testing.H6: the evaluation codes have been updated for the pump.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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Manufacturer Narrative
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H3: the code conclusion for the pump has been updated.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 from the healthcare providers and manufacturer representatives.The patient began intrathecal therapy in 2008 with a 20 ml pump.The device was replaced in 2014 with a 40 ml pump.The managing physician was not aware of any issues from 2014-2020 and took over the patient¿s care at some point in 2019.The patient had been stable in 2020 at 969 mcg/day of baclofen and the dose was reduced to 935 mcg/day to extend the refill intervals during the pandemic.At the (b)(6) 2020 refill the hcp had a difficult time accessing the pump and ended up using the longer refill needle.The refill was done per standard procedure.Later that day the patient presented to the emergency room (er) with loss of consciousness, lethargy, shallow breaths, and could not be roused.The patient was hypothermic and minimally responsive in the er.A computerized tomography scan (ct) was performed and it was normal.The dose was lowered to 100 mcg/day ¿ within 24 hours of the refill.The patient¿s nervous system improved however they were admitted.The patient had withdrawal symptoms 48 hours later.The patient¿s dose was changed back to 900 mcg/day, they were discharged, they returned to baseline, and the managing physician stated the patient was fine.On october 1st the patient was agitated, had increased tone, was itching, and experienced discomfort and pain.The patient was not s leeping.The dose was increased to 998 mcg/day and improved.It was noted the pump would be reaching end of service (eos) so a replacement surgery was scheduled.On (b)(6) the patient went in for a scheduled refill (to note this information conflicts with the previous report that the refill occurred (b)(6) 2020).The managing physician was unable to refill the pump and noted this was the first time they experienced this in 17 years.The physician¿s assistant (pa) used fluoroscopy to access the pump.The pa initially had a hard time locating the refill septum but was reportedly able to complete the refill per standard procedure using fluoroscopy.The surgeon noted they have not viewed the fluoroscopy images and questioned if it was possible the pa was in the catheter access port (cap) and injected the fluid through the cap.The pa denied that this occurred.Within hours of the refill the patient was coding in the er, was unresponsive, and was admitted.The pump was replaced on november 24, 2020.It was confirmed that the pump was not emptied when the device was removed.The surgeon and the rep present at the explant confirmed the reservoir was not aspirated upon removal and the device was immediately sealed for return for analysis.The surgeon noted there was free fluid around the pump when he removed the device and stated there could have been a pocket fill.The surgeon also stated it could have been dissolved blood or a seroma.The rep stated the managing physician¿s colleague, another managing physician at the practice, told the rep they believed a pocket fill had occurred at the refill in november.Troubleshooting considerations were reviewed with the managing physician at the time of the event and it was reviewed to aspirate the pump following the refill to determine if there was drug still in the reservoir.However, it was reported the physician did not aspirate the reservoir following the refill and wanted to know how much drug was in the pump after it was removed.
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