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); Pain (1994); Seroma (2069)
|
Event Date 10/01/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id 8780 serial# (b)(4).Product type; other relevant device(s) are: product id: 8780, serial/lot #: hg4743z13, ubd: 30-mar-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a patient who was receiving morphine (asked/unknown mg/ml at asked/unknown mg/day) via an implantable pump for unknown indications for use.It was reported that patient stated they were supposed to have a revision done because the catheter moved.Patient stated they found out about the catheter moving recently but about 2-3 weeks after the pump was implanted there was a build up of fluid the size of a fist at the catheter.Patient stated the hcp (healthcare provider) drained it but the fluid came back and spread across their whole side.Patient mentioned being on a blood thinner and do not know the dose or concentration but the hcp increased it.
|
|
Manufacturer Narrative
|
Continuation of d10: product id: 8780, serial#: (b)(6), implanted: 2020 (b)(6), explanted: 2022(b)(6), 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.
|
|
Event Description
|
Additional information was received from the patient and a healthcare provider (hcp) via a company representative who reported that the patient had fluid build-up at the spinal incision site and lack of pain relief.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The patient was referred to a neurosurgeon for a catheter revision.During the procedure, the hcp saw no issues with the catheter, but went ahead and replaced it.He also sutured closed what he said looked like a small csf (cerebrospinal fluid) leak and moved the pump from the patient¿s back to the abdomen.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.The pump was delivering morphine (10 mg/ml at 1.3 mg/day).Additional information was received on 22-apr-2022 from the patient who reported that she had the revision performed on tuesday, but they didn¿t program her ptm (personal therapy manager) because it was saying bolus is disabled.She stated that she was in excruciating pain and was wondering if it could be activated over the phone because her hcp was out of the office until next week.
|
|
Search Alerts/Recalls
|
|
|