MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-20 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problems
Cerebrospinal Fluid Leakage (1772); Purulent Discharge (1812); Unspecified Infection (1930)
|
Event Date 05/15/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id neu_unknown_cath serial# unknown implanted: (b)(6) 2015.Explanted: (b)(6) 2023.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown.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 a consumer regarding a patient receiving morphine via an implanted pump.The indication for pump use was non-malignant pain.It was reported that about a month after the patient¿s recent pump replacement, they noticed the pump was moving around.On (b)(6) 2023 the patient was taken to surgery to make the pocket more stable due to the stiches possibly breaking, but when they got in there, they said they saw a pocket of pus and ¿it just blew out, so they had a sticky, gooey mess¿.At that point, they took everything out and put the patient on antibiotics.The next day, the patient was leaking spinal fluid and it leaked for 2 months.The patient had blood patches and was just getting ready to come off of bed rest at the end of this week.
|
|
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 consumer (con) reported the patients weight.
|
|
Search Alerts/Recalls
|
|
|