MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Muscle Weakness (1967); Oversedation (1990); Pain (1994); Lethargy (2560); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, lot#: serial#: (b)(4), implanted: on (b)(6) 2008, explanted:, 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.

Event Description

Information was received from a healthcare provider (hcp) consumer who was receiving baclofen at unknown concentration and dose via an implantable pump for cerebral palsy and intractable spasticity.It was reported that the patient was going to have a dye study and they wanted to know what dye was used.It was indicated that for intrathecal use isoview and omnipague were commonly used.The hcp stated that the patient was in the hospital over the weekend due to being lethargic, somnolent, pain and severe spasticity.The hcp mentioned that they didn¿t see anything wrong with the pump and that they've had a lot of hospitalizations for that.The hcp mentioned that they were seen in a clinic on (b)(6) 2023 and were concerned the leak on the catheter was not consistently delivering drug.The hcp mentioned the patient had periods of oversedation and flaccidity alternating with severe spasticity.The patient also had a lot of issues with nephrolithiasis, a foley catheter and constipation, the hcp mentioned the patient was less constipated over the weekend.It was noted the patient had about 10 visits to the hospital over the last 6-10 months.It was stated the constipation was a little better controlled.It was mentioned that the patient had a foley catheter that may be contributed to some of the symptoms still but stated that it was better than the urinary retention.It was mentioned that the stones were treated aggressively with neu rology.The hcp stated that his managing physician left orders to do a dye study if patient returned with issues while the managing is on vacation.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16286951
• MDR Text Key: 308677422
• Report Number: 3004209178-2023-01525
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Date Device Manufactured: 01/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male