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

Model Number 8637-20

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Nausea (1970); Pain (1994); Cramp(s) (2193); Therapeutic Response, Decreased (2271)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The product was returned for analysis.The patient was not in a clinical study, the device was used with/in the patient for treatment, there was no patient death, and the patient recovered without sequela.It was reported that there was no patient injury.A dye study had been performed.The reason for the device removal was ¿refill amount off.¿ the loss of therapy was noted as ¿gradual.¿.

Manufacturer Narrative

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 manufacturer representative on (b)(6) 2020 regarding a patient receiving morphine (15mg concentration at 2.930mg/day) via an implanted infusion pump.It was reported that when the patient's refill nurse was refilling the pump, they noted an expected volume of 5cc but 10.5cc were withdrawn.The patient had withdrawal symptoms including nausea, cramping, and return of pain.Magnetic resonance imaging (mri) was performed and the catheter was not seen.Computerized tomography (ct) scan showed the catheter at t9.An intraoperative catheter dye study was completed with positive return of cerebrospinal fluid (csf) and dye was noted intrathecally (it).The pump was replaced and the issue was considered resolved.The patient met with the physician on (b)(6) 2020 and the reports were received at that time.There were no noted environmental, external, or patient factors that may have led or contributed to the issue.The patient's status at the time of report was alive - no injury and no further complications were reported or anticipated.

Manufacturer Narrative

Analysis of the pump revealed no anomaly.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.

• 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: 9738507
• MDR Text Key: 186235421
• Report Number: 3004209178-2020-03797
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2020

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: 11/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 02/21/2020; 04/16/2020
• Supplement Dates FDA Received: 03/13/2020; 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR