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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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| Model Number 8637-20 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Bacterial Infection (1735); Edema (1820); Erythema (1840); Unspecified Infection (1930); Rash (2033); Staphylococcus Aureus (2058); Seroma (2069); Swelling (2091); Complaint, Ill-Defined (2331); Fluid Discharge (2686)
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| Event Date 07/04/2020 |
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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 foreign healthcare professional (hcp) via a distributor regarding a patient who was receiving gabalon at a dose of 87.4mcg/day via an implantable infusion pump for cerebral palsy.The pump had been implanted (b)(6) 2020 and it was noted that immediately after the procedure, edema was developed and serous fluid came out.This was also described as an accumulation of serous fluid.It was reported that on (b)(6) 2020, a rash was developed on the site where the pump was implanted and the incision was sutured 1 or 2 weeks ago and it became swollen.Instead of pus, yellow transparent serous liquid came out of the pump implant site.No signs of infection were observed, but infection could have occurred mildly, per the report.It was reported unknown whether this liquid could be drained due to the product being used in the intrathecal space.The countermeasure was considered to be washing, administering antibiotics and draining the liquid.The causality of the event was unknown.The event outcome was unrecovered as of (b)(6) 2020.A visit was scheduled for (b)(6) 2020 or (b)(6) 2020.As of (b)(6) 2020, the distributor had requested additional details from that visit but no further information was yet received.
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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 foreign healthcare professional (hcp) via a distributor.It was further clarified that the date of incidence was (b)(6) 2020.It was reported that on (b)(6) 2020, edema was developed after the procedure.It seemed that serous fluid had accumulated, so the issue was dealt with by compressing the area.On (b)(6) 2020, ¿something like mold¿ appeared on the compressed area; this was treated with ¿ointment, etc.¿ on (b)(6) 2020, there was no problem with no infectious symptoms such as fever in the patient's symptoms.Serous fluid was cultured; mrsa was detected, but it was highly possible that superficial bacteria were picked up.White blood cell count and eosinophil were normal and rather low.Allergic agents were administered just for making sure.Serous fluid was drained.On (b)(6) 2020, there was no problem with no infectious symptoms such as fever in the patient's symptoms.Serous fluid was drained (1-2 cc/day).It was the attending physician¿s assessment that the amount of serous fluid decreased when the allergic agent was additionally administered from (b)(6) 2020.There was a reaction for (b)(6), but it was considered that superficial ones were detected on the skin.¿follow-up would like to be performed without any inflammatory reaction with the marker etc.¿ a contact would be made after (b)(6) 2020.There might have been irritation due to the position of the pump due to replacement of the pump, but the cause was not clear.There was no relationship with the drug and the catheter.The causality was not attributed to the drug, catheter, pump, or programmer.The outcome was ¿remission¿ on (b)(6) 2020.[additional] information regarding the patient's medical history and concomitant medications was unknown.
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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 was received.It was indicated on (b)(6) 2020 there was a ¿change in the symptoms,¿ however, a correction was made indicating there was no change in the symptoms.The product would not be returned as it was discarded.
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Manufacturer Narrative
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H6: patient code (b)(6) no longer applies, patient code (b)(6) no longer applies.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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Event Description
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Additional information was received from a foreign healthcare professional (hcp) via a distributor.It was reported that on (b)(6) 2020 the patient developed a rash on the compressed site.On (b)(6) 2020, locoidcream was prescribed.On (b)(6) 2020, 10g of nizoral cream (2%) was prescribed.On (b)(6) 2020, dexamethasone was prescribed.On (b)(6) 2020, edema was observed at the implantation poc ket site after administration of flomox for 5 days.On (b)(6) 2020, there was a ¿change in the symptoms¿.On (b)(6) 2020, symptoms improved when administration of nizoral was discontinued.On (b)(6) 2020, redness at the implantation pocket site was observed; there was effusion.On (b)(6) 2020, the effusion was drained.Administration of flomox was discontinued, and clavamox was used instead.On (b)(6) 2020, mrsa was 2+ after culturing the bacteria.However, there were no infection symptoms and it was suspected that superficial bacteria were detected.The drain was inserted and effusion of 2 to 3cc was drained.On (b)(6) 2020, ss a countermeasure against mrsa, cybox was administered ¿just in case¿.Administration of clavamox was continued.As a countermeasure against serous fluid, alesion was administered.On (b)(6) 2020, when the patient was placed on the buggy from the bed, 7 to 8cc of serous fluid came out.On (b)(6) 2020, the drain was removed and switched to hydrocolloid dressing.Fibrate spray and ag gentle were prescribed.On (b)(6) 2020, mrsa was negative.On (b)(6) 2020, the pump was removed.It was noted that the patient¿s concomitant drugs included flomox, and according to the physician¿s assessment, the ¿flomox administered on (b)(6) 2020 seemed to be the cause of effusion.Although no infection occurred, the patient's family was concerned about the risk of infection due to the use of drain etc., removal of the pump was strongly requested and the pump was removed on (b)(6) 2020 as a result.Regarding the generation of serous fluid, it was told that the ribs were in contact with the upper part of the pump and were stimulated by the re-implantation of the pump, so serous fluid was generated.The main cause might be that the fixed position (shape of the pocket) of the pump changed due to growth (it was judged that it was not an issue of the procedure).
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Manufacturer Narrative
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Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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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