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

Model Number 8637-40

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

Patient Problems Erythema (1840); Fever (1858); Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Seroma (2069); Tachycardia (2095); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products:¿product id 8598a lot# serial# n289696005 implanted: (b)(6) 2011 explanted: (b)(6) 2023 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8598a, serial/lot #: n289696005, ubd: 02-may-2013, udi#: (b)(4).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

Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving gablofen 500 mcg/ml at 125 mcg/day.It was reported the patient had developed a urinary tract infection in mid-march and antibiotic treatment had been initiated.After three days of treatment the patient reported redness and swelling at pump incision site.The patient had then been started on cephalexin, but after a few days they did not show any improvement and began having a fever of 103, tachycardia with a rate of 130, and the patient had been admitted to the emergency room with a diagnosis of sepsis.Intravenous antibiotics vancomycin and zostavax were initiated along with intravenous fluids.And ekg showed supraventricular tachycardia, so the patient had been given adenosine with a return to normal sinus rhythm.They had developed supraventricular tachycardia again and given diltiazem with a return to normal sinus rhythm.The patient developed low blood pressure and was transferred from the emergency room to the icu.Upon admission to the hospital an abnormal ct scan revealed a fluid collection over the pump pocket site, and the neurosurgeon noted it measured up to 1400 ml.The pump and catheter were reported to be explanted without complications.

Manufacturer Narrative

Continuation of d10: product id 8598a lot# serial# (b)(6) implanted: (b)(6) 2011 explanted: (b)(6) 2023 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 received from the healthcare provider via a clinical study indicated that cellulitis was noted on the patient's skin associated with the pump pocket by patient mother.It was reported that the patient experienced decreased capillary refill in all extremities, tachycardia.The pump was explanted and wound debridement was performed.

• 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: 16710077
• MDR Text Key: 313004986
• Report Number: 3004209178-2023-04782
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• 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: 05/18/2023
• Date Device Manufactured: 08/30/2017
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 63 KG