MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problems
Pain (1994); Vomiting (2144); Anxiety (2328); Distress (2329); Depression (2361); Sleep Dysfunction (2517); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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Information was received from a consumer via a manufacturer representative regarding a patient who was receiving dilaudid (hydromorp hone) at unknown concentration and dose via an implantable pump for non-malignant pain.It was reported that patient stated that the healthcare provider (hcp) has let the pump run out for a 3rd time.Patient stated the hcp let the pump run out (b)(6) time.Patient stated they thought it was the flu but it was him going through withdrawals because the pump was empty.Patient stated then around labor day the pump went empty again and they ended up in the hospital.Patient stated then again (b)(6) the pump went empty.Patient stated their anxiety was high, depression was high, withdrawals, throwing up, cannot eat/drink or cannot sleep.The issue was not resolved through troubleshooting.Additional information stated the patient symptoms were resolved.The patient was seeing by a different hcp on (b)(6) and (b)(6).Hcp reported that patient accidentally came to our office on (b)(6) 2021 and was on different concentration and dose that was too high.
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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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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 reported that they had called previously about getting referrals for doctors that will refill his pump because his doctor will not refill it.The patient called those referrals and was told that those health care providers only implant pumps, they do not refill them.The patient wanted more referrals of doctors to try.The patient stated their pump has been empty for three months and that they are in a lot of pain because they are no longer getting medication from the pump.The patient stated because the pump has been empty, the patient is so stressed out they have had to go to the psychiatric ward.
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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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