MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problem
Infusion or Flow Problem (2964)
|
Patient Problems
Nausea (1970); Vomiting (2144); Burning Sensation (2146); Dizziness (2194)
|
Event Date 10/06/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2005, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 14-aug-2006, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a consumer and a healthcare provider (hcp) via a company representative regarding a patient receiving baclofen (30 mcg/ml at 9.663 mcg/day), bupivacaine (10 mg/ml at 3.221 mg/day), and sufentanil (300 mcg/ml at 96.63 mcg/day) via an implanted pump.The indication for pump use was non-malignant pain.The patient reported falling on her pump.Two days later ((b)(6) 2021), she went to the er due to nausea, dizziness, and vomiting.She also had a burning sensation around her pump and her back especially when she used her ptm (personal therapy manager).The pump had been working fine before the fall.A dye study was attempted, but the catheter could not be aspirated.The environmental, external, or patient factor that may have led or contributed to the issue was noted to the patient¿s fall.A catheter revision was planned, but not yet scheduled.The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event.
|
|
Event Description
|
Additional information received reported the patient was having a catheter revision on (b)(6) 2021.After opening the pocket, the ph ysician still could not aspirate from the cap (catheter access port).They attempted replacing the pump connector.A new catheter was implanted and connected to the existing pump.
|
|
Manufacturer Narrative
|
Continuation of d10: product id: 8709, serial# (b)(6), implanted: (b)(6) 2005, explanted: (b)(6) 2021, and 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.
|
|
Search Alerts/Recalls
|
|
|