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 Abdominal Pain (1685); Adhesion(s) (1695); Cellulitis (1768); Erythema (1840); Unspecified Infection (1930); Seroma (2069); Vomiting (2144); Swelling/ Edema (4577)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving compounded baclofen (unknown dose and concentration) via an implantable pump.It was reported erythema and edema was noted over the pump site of unclear etiology.It was noted there did not seem to be any fluctuance, and did seem to be going into baclofen withdrawal to suggest that there was a problem with the pump.An ultrasound (us) demonstrated fluid collection and possible cellulitis on (b)(6) 2020.Device interrogation was normal on (b)(6) 2020.An x-ray revealed the pump and catheter appeared normal.On (b)(6) 2020 keflex was prescribed and extra office visits were scheduled to monitor.It was noted that given the patient's recent abdominal surgery in august, follow by abdominal pain and emesis post operatively, it was certainly possible that they have an infection that has seated into their pump pocket.The outcome of the event resolved with sequelae.The sequelae was noted as what seemed like adhesions on the lateral border of the pump, which were not painful.To palpation.The pump site itself was no longer red.The clinical diagnosis was cellulitis near the pump site.The event resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function.The etiology of the event indicated the relationship of the event to the device or therapy was unlikely related and indicated the relationship of the event to the implant procedure was not related.The incisional site/device tract was pump pocket.The event date was (b)(6) 2020.

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 from a healthcare professional (hcp) via a clinical study reported as noted in treatment section, the patient was prescribed antibiotics and extra wound care checks were scheduled with neurosurgery to ensure appropriate healing.

• 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: 12474099
• MDR Text Key: 271466786
• Report Number: 3004209178-2021-13854
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Weight: 45