MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Seroma (2069); Discomfort (2330); Increased Respiratory Rate (2486); Sleep Dysfunction (2517); Fluid Discharge (2686); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 06/12/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving hydromorphone (4.6 mg at 0.70008 mg/day), bupivacaine (20.0 mg at 1.00011 mg/day ) and fentanyl (2000 mcg at 100.01085 mcg/day) via an implantable pump.It was reported the patient had a small hole about the size of a q-tip without the cotton on it that was oozing clear fluid on (b(6) 2021.It was noted the pump pocket was swollen and tender.The patient was seen and there were 3 small 3mm openings with small draining, cannot see the pump or notable abscess.The patient was started on bactrim.Cultures were taken and an appointment was scheduled for (b)(6) 2021.It was indicated the event was possibly related to the device or therapy.The clinical diagnosis was infection and inflammatory reaction due to other nervous system device.The event was ongoing.
|
|
Event Description
|
Additional information was received from the healthcare provider (hcp) via the company representative (rep).The patient called the clinic stating there was a small hole about the size of a q-tip without the cotton on it that was oozing clear fluid.The hole was described as being over the pump, within the incision line on the lateral aspect.The patient went to the emergency room for evaluation on (b)(6) 2021.There was a small three millimeters (mm) site of wound dehiscence to the later aspect of the surgical scar that was draining small cloudy fluid, according to the communication note.The patient noticed the infection about four days earlier (relative to (b)(6) 2021).The patient presented on (b)(6) 2021 for evaluation in addition to a pump reprogram for ongoing evaluation of other pain-related issues such as psychosocial and emotional adjustment, the need for oral medication monitoring, addition or adjustment, and evaluation of functional ability.The pump site was swollen and red with increased pain on the right side.The patient¿s chief complaint was abdominal pain on the left side and lower back pain bilaterally.The pain was rated at 10/10.The pain was described as burning, throbbing and sharp.The pain was more intense than previously with the precipitating cause provided as infection with pain at the pump site.The patient was breathing rapidly and pleading for help.The patient was not able to sleep because of the pain.The patient stated they were not getting any pain relief from the pump, stating ¿i¿ve used it every hour hoping that it would help and it¿s not doing anything.¿ the patient stated, ¿the pain is so bad i want to shoot myself.¿ the patient denied any serious suicidal ideation.The patient was provided with ice and two 5 milligram (mg) percocet in the clinic.Surgery was planned to remove the system due to infection.The patient would be prescribed oral pain medication.The patient¿s diagnoses included: infection and inflammatory reaction due to other nervous system device, implant or graft, initial encounter and other chronic pancreatitis.The patient¿s pump and catheter were explanted on (b)(6) 2021.It was noted the issue was resolved at the time of the report, (b)(6) 2021.The patient¿s allergies included: droperidol and tramadol (for which they experienced shortness of breath).The patient¿s past medic al/surgical history included: add (attention deficit disorder) / adhd (attention deficient hyperactive disorder), anxiety, depression, gestational diabetes, infection of kidney, and apnea.It was noted the patient had a history of abdominal pain secondary to pancreatitis.The patient had a congenital pancreatic anomaly and was status post pancreatectomy.Additional information received from a healthcare provider via a clinical study reported the pump was removed from the site, on 2021 -jun-15, and the spinal catheter was tied off.Cultures were collected and the area was somewhat necrotic.On (b)(6) 2021, the patient was in the er reporting build up over the old pump site.It was noted the cultures were positive for staph.
|
|
Manufacturer Narrative
|
H6 correction: patient code e2317 (granuloma) does not apply to 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.
|
|
Manufacturer Narrative
|
H3 ¿ non-destructive analysis found that there were no anomalies and no further destructive testing was required.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.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Additional information received from a healthcare professional (hcp) via a clinical study reported on (b)(6) 2021 the old pump site was swollen and 30cc of fluid was removed and submitted for cultures.On (b)(6) 2021 the old pump site was dehisced, and had purulent discharge.The patient had an appointment with infectious disease.On (b)(6) 2021 the wound was presenting with discharge.On (b)(6) 2021 the patient reported wounds were closed and no discharge.On (b)(6) 2021 the patient was cleared by infectious disease hcp and was scheduled for re-implant of pump.The outcome of the event resolved without sequelae on (b)(6) 2021.
|
|
Event Description
|
Additional information received from a healthcare professional (hcp) via a clinical study reported the cultures taken on 2021-jun-21 were negative for growth.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|