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

Model Number 8637-20

Device Problems Particulates (1451); Pumping Stopped (1503); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Intermittent Infusion (2341); Device Ingredient or Reagent Problem (2910); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id 8703w lot# l54366 implanted: (b)(6) 1998, product type catheter; ubd: 03-aug-2000, udi#: (b)(4).Event date is approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient receiving 20 mg/ml of dilaudid at 6.03 mg/day via an implantable pump for non-malignant pain.It was reported on (b)(6) 2018 a volume discrepancy occurred at a scheduled refill.The expected residual volume was 2.0 ml, and the actual residual volume was 11.0 ml.It was reported the patient¿s pain had not been managed as well as it previously had been.The pump was refilled with 20 ml of new drug and the patient was going to be scheduled for a dye study.There were no environmental/external/patient factors provided.No interventions/actions had been taken, per the rep.The issue had not been resolved.It was indicated surgical intervention had not occurred, and had not been scheduled, but it was planned.The patient¿s status at the time of the report was provided as ¿alive-no injury.¿ the patient reported they had been using a pump for 20+ years and reported their pump had not been operating properly for about a month.The patient stated they were calling to inquire about the recommended concentration of dilaudid.Patient services reviewed that they were not the manufacturer of the medication and redirected the patient to speak with their healthcare provider.The patient again asked if there were recommendations on the concentration level of medication being used.Technical services reviewed the applicable information.The patient stated their healthcare provider was ¿concerned about the concentration level being in the 20.¿ technical services reviewed approved drugs and applicable information for the patient¿s device/therapy.It was also reviewed that this was a medical decision made by the healthcare provider.The patient reported they were concerned about the dilaudid used with their infusion therapy.It was indicated the medication would be sent off for analysis.Patient reported the dilaudid was crystallized, and the color had changed.The patient stated it looked like an apple, ¿real hard pea.¿ however, it was normally clear in color.The patient inquired if their pump should be replaced, and if minimum rate mode would accidentally ¿push less time.¿ the patient asked if there were particles in the fluid and a color change, would the pump need to be taken out.Technical services reviewed they could not speculate regarding the question with the information available.The patient also stated there were ¿two lines¿ in his back, and there was not an issue with one of the lines.The patient stated he did not want to get the pump replaced.The patient questioned if there were any recalls on the pump.The patient referenced a non-malfunction-zero alarm for the pump, and was wondering if there was anything built into the pump that would track volumes put in, etc.The patient also asked if there was a recall related to flow problems and stated within the last six years they had a new ¿line¿ put in (please refer to mfr report #6000030-2015-00119 regarding this event).Patient services reviewed applicable recalls with the patient.It was indicated the patient got upset.The patient inquired if there was a programming procedure or capability to track if there was a flow issue.The patient also asked if the alarm reservoir was based upon estimation or use.Technical services reviewed that the there was not a sensor in the pump, the device strictly runs off concentration.Technical services reviewed if there was some sort obstruction the alarm would not be triggered.The only way the patient would know if there was an obstruction would be if they experienced a change in symptoms or the healthcare provider was pulling out more medication than expected.The patient stated they would not function without the pump.The patient also asked if the manufacturer had procedures for refilling the pump, and said the manufacturer had to have procedures to refill the pump.The patient stated their doctor¿s office draws ¿really hard¿ on the syringe to get all the medicine out of it.The patient questioned if there was a ¿built in one-way valve on the pump so it doesn¿t draw out the catheter line.¿ technical services reviewed that there is a manual for refill procedures that goes with the kits.Technical services reviewed they cannot speak to whether or not the patient¿s healthcare provider follows the procedure but would share the information with the patient.The patient stated, ¿something went on¿ and they could not believe their pump was only two years old and would not show any warning for an issue.No out of box failures were reported.No medical or therapy problems related to a small part were reported.Other medications being taken at the time of the event, the patient¿s weight, and medical history were unknown and would not be made available to the manufacturer.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturing representative (rep) on april 13, 2018.The rep reported the dye study showed the catheter was patent.The pump was replaced (b)(6) 2018.No changes were made with the catheter as there were no issues detected.The patient was doing fine when the rep last followed-up.Regarding the motor stalls in the log, the patient stated they were not exposed to any electromagnetic interference (emi).Regarding the previously reported drug information, the physician had told the rep that the drug was yellow in appearance during a refill, and the drug had been sent to their own pharmacy for analysis (prospira).The rep was unaware of what the patient was referring to in regards to the patient's comment, "there were 'two lines' in his back, and there was not an issue with one of the lines." the rep had no further information at the time.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.The evaluation codes have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative (rep).The pump was returned to the manufacturer for analysis.Per the pump interrogation log, the device was examined on (b)(6)2018, with the last change occurring on (b)(6)2018.The pump was delivering 5.313 mg/day of dilaudid at the previously reported concentration (20 mg/ml).The elective replacement indicator (eri) was at 53 months.The logs indicated a motor stall occurred on (b)(6)2018 at 12:55, and recovered the same day at 13:20.A second motor stall occurred on (b)(6)2018 at 9:26, and recovered the same day at 9:51.

Manufacturer Narrative

Evaluation of implantable pump serial number (b)(4) revealed wear on the motor o-ring.However, the wear did not affect the performance of the device during functional testing in the lab.The pump motor function was within specification.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H6.All applicable event codes have been updated/corrected.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
• 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: 7367144
• MDR Text Key: 103403275
• Report Number: 3004209178-2018-05651
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male