MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bacterial Infection (1735); Calcium Deposits/Calcification (1758); Incontinence (1928); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Sepsis (2067); Stenosis (2263); Insufficient Information (4580)
|
Event Date 11/01/2021 |
Event Type
Injury
|
Event Description
|
Information was received from a friend/family member regarding a patient who was receiving therapy via an implantable pump for unknown indications for use.It was reported that around (b)(6) 2021 the patient began experiencing paralysis symptoms.It was discovered during back surgery that the patient had calcification at the tip of the catheter.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 08-mar-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 8780, serial# (b)(6), implanted: (b)(6) 2016, 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 consumer indicated that the patient had severe cord compression and stenosis at t9-t10 and 10/t11 due to an overgrowth.He was discharged to a rehab facility where he became progressively weaker and eventually became incontinent of bowel and bladder functions.Upon evaluation he was found to be completely paralyzed below the umbilicus.Surgical decompression and stabilization was performed to to improve the patient's back pain.Post surgery the patient gave up on eating and drinking and ¿had no quality of life¿.
|
|
Search Alerts/Recalls
|
|
|