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

Model Number 8637-40

Device Problems Filling Problem (1233); Premature Elective Replacement Indicator (1483)

Patient Problems Hematoma (1884); Nausea (1970); Seroma (2069); Vomiting (2144); Weight Changes (2607)

Event Date 03/01/2016

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 foreign healthcare provider (hcp) via a manufacturer representative on 2(b)(6)2020 regarding a patient receiving levobupivacaine (7.5mg/ml at 8.3mg/day) and clonidine (2mcg/ml at 123mcg/day) via an implanted infusion pump.The patient's medical history included pain.It was reported that the elective replacement indicator (eri) was at "2/12" even though the pump had only been implanted in (b)(6) 2016.It was noted that following implant, the patient was quite unwell immediately post with severe nausea and vomiting.This continued for a few weeks and would resolve for a short period of time, however, the symptoms would return again and resulted in a drastic weight loss for the patient.The patient had a number of investigations carried out including computerized tomography (ct) of the abdomen with no abnormality detected (nad), a gastro referral with no conclusive results, and an epidural to see that all was ok with nad.The only thing that helped to resolve the symptoms was the use of cyclizine, however, it appeared to have settled over the last few months prior to the pump change.It was noted that when the nurse used to do the pump refills, they would encounter fluid which would sometimes block the needle.The pain team thought this was a seroma, however a sample of this fluid was sent for analysis and came back nad.The patient was having their pump replaced on (b)(6) 2020 and during the procedure, a fluid collection was noted in the abdomen/pocket around the implant site.The fluid was dark red/brown in color.The physician had previously thought this was a seroma, however, the color was not what was expected so a sample was sent for analysis.Results were still pending at the time of report.There was also a piece of tissue over the top of the pump that was red/brown in color.This was thought to be a piece of residue from the capsule loose over the top of the pump, and was sent for analysis, with no anomalies reported.There were no known environmental, external, or patient factors that may have led or contributed to the issue.The wound was washed out thoroughly prior to replacement and the issue was considered resolved.No further surgical intervention occurred or was planned related to this event and the patient's status at the time of report was alive - no injury.No further complications were reported or anticipated.

Manufacturer Narrative

The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.The returned device passed all testing in the laboratory and no anomalies were identified.H6: device code c63315 no longer applies.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 a foreign healthcare professional (hcp) via a manufacturer representative.It was reported that the nurse believed that the pump not lasting the full expected time was due to the prescription.

• 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: 10154195
• MDR Text Key: 195136380
• Report Number: 3004209178-2020-10341
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention