MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Scar Tissue (2060); Swelling (2091); Ulcer (2274); Impaired Healing (2378); Fluid Discharge (2686); Foreign Body In Patient (2687); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/30/2020 |
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 healthcare provider (hcp) via a clinical study on (b)(6) 2020 regarding a patient receiving fentanyl (1000mcg at 199.83737mcg/day) and bupivacaine (10mg at 1.99837mg/day) via an implanted infusion pump.It was reported that on (b)(6) 2020 the hcp received a call from the emergency room (er) indicating that the patient fell about 5 days ago and had since developed cellulitis, swelling, and drainage.Infectious disease was consulted in the morning, and it was noted that the pump would be removed.The clinical diagnosis was infection and dehiscence at the pump site.On (b)(6) 2020 the patient was in for reprogramming and to schedule the pump removal procedure.The event was ongoing and resulted in an unscheduled clinic/office visit as well as in-patient hospitalization.The etiology indicated that the event was possibly related to the device/therapy and was unlikely related to the implant procedure.
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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 an hcp via a clinical study indicated that the patient underwent a procedure on (b)(6) 2020 to remove the pump and tie off the spinal catheter.Three cultures were sent from the spinal catheter wound, pump pocket wound, and cerebrospinal fluid (csf) from the catheter.
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Event Description
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Additional information was received from the consumer and the healthcare provider (hcp) via the manufacturer's representative (rep) on (b)(6) 2020.It was reported that the patient had poor healing at their pump pocket site after they fell on the pump pocket.It was also confirmed that, during the reprogramming session on (b)(6) 2020, the patient experienced an infection over the pump site.The patient had profuse pus draining out of the pump pocket incision, redness around the pump spreading to the hip area, a "dime-size area of black eschar" to the lateral pump site, and a white sore on the medial pump site.The pump was tapered down at that time and the patient was given a prescription of keflex, fentanyl 25 mcg patch and 5mg of oxycodone.The pump segment of the catheter was explanted with the pump on (b)(6) 2020 but the spinal segment was left implanted for a future implant.The issue was considered resolved at the time of the report.The patient¿s medical history included depression, apnea, nerve damage, thoracic spine pain, back surgery, shoulder surgery, carpal tunnel release, spinal fusion in cerbical and lumbar region, allergies to dilaudid and morphine, low back pain, postlaminectomy syndrome, lumbar region radiculopathy, intervertebral disc disorders with radiculopathy in the lumbar region, hypertension, hyperlipidemia, mild copd/emphysema the patient¿s concomitant medications included 2% acetic acid ear solution, 81 mg aspirin 1 tablet by oral route every day, 300 mg/24 hr bupropion hcl xl tablet 1 tablet by oral route every day, 15 mg buspirone tablet 1 tablet by oral route 3 times every day, 25 mg carvedilol tablet 1 tablet by oral route 2 times every day with food, 6.25 mg carvedilol tablet 1 tablet by oral route 2 times every day with food, 30 mg of duloxetine capsule 1 tablet by oral route every day, 0.4 mg capsule of flomax 2 capsules on day 1 then 1 capsule per day, 600 mg gabapentin tablet 1 tablet by oral route 3 times every day, lidocaine-prilocaine 2.5%-2.5% topical cream, 1 mg/ml of naloxone 1 ml by intravenous route over once may repeat at 2 to 3 minute intervals as needed, 4 mg/actuation nasal spray of narcan 0.1 ml by intravenous route over once may repeat at 2 to 3 minute intervals as needed, 0.4 mg nitroglycerin sublingual tablet 1 tablet by sublingual route every 5 minutes as needed for chest pain no more than 3 doses in 15 minutes, 20 mg omeprazole tablet, 10% ovace plus topical cream, 10 mg oxycodone tablet 1 tablet by oral route 2 times every day as needed, 10 mg oxycodone tablet 1 tablet by oral route up to 4x/day as needed day as needed, 5 mg oxycodone tablet by oral route every 4 hours as needed for pain, 5 mg oxycodone tablet by oral route every 4 -6 hours as needed, 2.5 mg ramipril capsule 1 capsule by oral route every day, 20 mg r osuvastatin tablet 1 tablet by oral route every day, 8.6 mg senna tablet 2 tablets by oral route every day as needed for constipation, 200 mg/ml of testosterone cypionate intramuscular oil 0.25 ml by intramuscular route every 4 weeks, 50 mg tablet of trazodone 1 t ablet by oral route every day at bedtime.!% voltaren topical gel 2 grams by topical route 4 times every day to affected areas.
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Manufacturer Narrative
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Concomitant medical product: product id 8784 serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2020 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.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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H6: updated to include annex f codes 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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Continuation of d10: product id 8784 lot# serial# (b)(6), implanted: (b)(6)2020, explanted: (b)(6) 2020, product type catheter h3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.The returned pump was interrogated and as per the logs the following medications were being administered as of (b)(6)2020: fentanyl (concentration: 2,000 mcg/ml, dose rate: 199.8 mcg/day) and bupivacaine (concentration: 5.0 mg/ml, dose rate: 0.4996 mg/day).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 via a company representative.The pump and catheter component was returned to the manufacturer for analysis.Additional information was later received from a healthcare provider via a clinical study on (b)(6) 2020.The pump administered fentanyl (2000 mcg) at a dose rate of 399.67474 mcg/day and bupivacaine (5 mg) at a dose rate of 1.25031 mg/day.
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Manufacturer Narrative
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H3: analysis of the pump identified no anomalies.Analysis of the catheter identified no significant anomalies.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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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 professional (hcp) via a clinical study reported the outcome of the event resolved without sequelae on (b)(6) 2020.No further complications were reported/anticipated.
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Event Description
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Additional information received from a consumer reported the patient stated the last pump they had, had to be explanted due to the patient having a staph infection.It was noted it was determined "around (b)(6) 2020".It was noted they removed the pump and could not implant a new one for 3 months until the patient healed.When asked what medication was in the pump at the time, the patient stated one started with the letter "l" and one started with the letter "b" (they think), but it gave the patient issues with urination.Troubleshooting was not required.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.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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