MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problems
Pumping Stopped (1503); Obstruction of Flow (2423); Failure to Disconnect (2541); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/25/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id 8780, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: ubd: 16-jan-2020, udi#: (b)(4).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
|
Information was received from the healthcare professional (hcp), via a manufacturer representative (rep) regarding patient receiving morphine (4.3 mcg/day/25 mg/ml) via an implantable pump.It was reported that motor stall and recovery occurred numerous times.The pump alarmed on (b)(6) 2022 and prior also, it was noted in the logs.The environment/patient factors were unknown.There was no troubleshooting.The pump was scheduled to be replaced.When opening the pocket and disconnecting the catheter, the white plastic portion pulled off.Also, poor cerebrospinal fluid (csf) flow was noted.When dissecting to remove/replace pump segment, the doctor found what looked like a greater than ninety angle or kink in the catheter.The pump segment and pump were replaced.The patient weight and medical history were asked and will not be made available due to legal/confidential reason.The patient status is alive and no injury.
|
|
Manufacturer Narrative
|
H3: destructive analysis of the pump identified wear on the motor o-ring for gear number three.Analysis of the catheter identified a kink in the catheter body.Visual inspection identified there was damage to the transition tubing.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
|
|
|