|
MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
| Model Number 8637-20 |
| Event Date 11/11/2019 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Concomitant medical products: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2010, product type catheter.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
Information was received from a consumer regarding a patient who was receiving morphine of an unspecified concentration at an unspecified dose rate via an implantable pump for non-malignant pain.It was reported that the patient¿s pump was broken.On (b)(6) 2019 the patient had a knee replacement surgery, and two weeks after her surgery she had a fall and the pump had not worked since then ((b)(6) of 2019).If was further indicated that the pump was not working due to a fall.The date (b)(6) 2019 is considered an approximate date of event (year known only).A healthcare provider (hcp) told the patient that the pump needed to be surgically removed from the left buttocks.The patient had been working with a physician to find a surgeon that would take her insurance and remove or replace the pump, but the patient was having a hard time finding a surgeon.The patient was described as having been very upset and was in a lot of pain.The patient was taking oral morphine for pain and the pump was set to the lowest dose possible of morphine.It was noted that the oral morphine was very different from getting it through the pump.The patient felt like she was on a mary-go- round.The patient was not going to sleep at the same times and was not waking up at the same times.The patient went through withdrawals for four days after the pump stopped working.The patient was shaking and ¿everything else¿.It was described as an awful experience and the patient was in extreme pain.No further patient complications have been reported as a result of this event.
|
| |
|
Event Description
|
|
Additional information was received from the rep on 2020-jun-12.One doctor said the pump is probably working and there are no alarms, but the other doctor didn't want to do a dye study and wanted to send patient to a surgeon.No further actions have been taken.Patient still has increased pain but nothing has been planned yet.Pump is implanted in service.No plans to remove yet and the only reason patient states the pump is broken is because she has increased pain.There were no further complications reported/anticipated.
|
| |
|
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
|
|
On 2020-june-25, additional information was received from an healthcare professional (hcp), via a manufacturer representative (rep).It was reported the patient fell down and thought they "damaged" the pump.No symptoms or signs were recorded from the patient.A possible catheter dye study was going to be performed at a future date, but this was still to be determined (this was indicated as a planned surgical intervention, but is not considered an actual surgical intervention).No interventions or actions were taken at the time of this report.It was unknown if the issue was resolved at the time of this report.
|
| |
|
Manufacturer Narrative
|
|
Continuation of d11: product id: 8709sc, serial# (b)(6), implanted: (b)(6) 2010, 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.
|
| |
|
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 was received from a company representative (rep) indicated the pump was replaced on (b)(6) 2020 and the surgeon felt there was nothing wrong with the pump.It was noted they performed a dye study and it was successful.The surgeon agreed to get it done due to the patient requesting.The rep had the pump and would be sending it back for analysis.
|
| |
|
Event Description
|
|
Additional information received reported that the patient claimed the pump was not working and demanded a replacement.The patient had a loss of therapy.A rotor study was not done and a dye study was aborted due to patient vasovagal episode.The patient recovered without sequela.
|
| |
|
Manufacturer Narrative
|
|
H3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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: analysis of the pump revealed no anomaly.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
|
|
|
