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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Rash (2033); Swelling (2091)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, lot#: hg3jsvh13, implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot#: (b)(4), ubd: 29-jun-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider via a distributor regarding a patient receiving gabalon at a dose of 25m cg/mday via an implanted infusion pump for an indicated use of severe spastic palsy (paraplegia).It was reported that the pump was implanted on (b)(6) 2020, and after 10 days, the inside of the pump pocket swelled and the patient had a rash and fever.The inside of the pump pocket was checked and infection was confirmed.After that, the inside of the pump pocket was cleaned and treated, but meningitis occurred associated with the pump pocket infection.The pump and catheter were removed on (b)(6) 2020.After the operation, the patient was thoroughly instructed to rest, but it was said that the failure to do so was the cause of the infection in the pump.The causality of the event was noted to be not related to the drug, catheter, pump, programmer, or surgical procedure.The severity of the event was classified as "serious" and the outcome at the time of report was unrecovered.No further complications were reported or anticipated.

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 in response to a request to follow-up indicated that the devices would not be returned for analysis as they were discarded.

• 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
• MDR Report Key: 10174822
• MDR Text Key: 198956494
• Report Number: 3004209178-2020-10679
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR