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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182); Component or Accessory Incompatibility (2897)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

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 professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal morphine 2000 mcg/ml at 4240,9 mcg/day, ropivacaine (naropin) 9250 mcg /ml at 19614,2 mcg/day, and prialt/ziconotide 0,8 mcg/ml at 1,69636 mcg/day via an implantable pump.It was reported that there was a discrepancy between expected volume and emptied volume from the pump.It seemed that 3 weeks ago [from (b)(6) 2021], the pump was found empty when it should have contained 11 ml of medication.The neurosurgeon and his team did not use the medtronic 8551 refill kit when performing the pump refill.They used devices directly found in the hospital (needle, syringe,etc.).The needle used had a diameter of 21 gauge.It was suspected that this syringe damaged the septum of the pump.The event occurred on an unknown date in (b)(6) 2021.Catheter opacification was performed and did not show any issue on the catheter.A scanner was also performed, and no issues regarding pump and catheter connection were found.The most probable issue seemed to be a liquid leakage.It was noted that the hcp had performed multiple refills, and human error leading to a pocket fill was excluded.The pump was replaced, and the new pump was connected to the initially implanted catheter.The issue was resolved.The patient's status was alive - no injury.The pump would be returned to the device manufacturer.Inform ation regarding the patient¿s age, weight, medical history, and other medications was unavailable.

Manufacturer Narrative

H3: 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.Visual inspection identified damage to the septum that resulted in a leak.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: 11282694
• MDR Text Key: 231011047
• Report Number: 3004209178-2021-02016
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention