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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 04/25/2018

Event Type  malfunction  

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) regarding a patient receiving intrathecal fentanyl 1000 mcg/ml at 220.2 mcg/day and bupivacaine 22.7 mg/ml at 4.999 mg/day via an implanted pump for non-malignant pain.It was confirmed via the event logs that the pump was not updated at the last pump refill where 40 milliliters (mls) of drug was placed in the reservoir (b)(6) 2018.On (b)(6) 2018, was the low reservoir alarm date via the print report, but the pump was critically alarming with 0 mls per the software.The hcp thought he programmed and updated the pump with 40 mls back on (b)(6) 2018.Per the software 40.4 cc was dispensed since the last update.It was the patient was hurting/increased pain so he programmed a bolus dose on the date of this report, but the patient could not feel it.The event date was the increased pain was (b)(6) 2018.The hcp changed the alarm volume from 1-2 mls and programmed the reservoir volume conservatively based off calculations so the new low reservoir alarm date was now (b)(6) 2018.It was noted the patient had respiratory problems, which had always been an underlying issue along with frequent pneumonia, copd, and emphysema (about 10 years) and was progressively getting worse over the past 6 years.The patient was over 90 years old and did not believe these medical issues were related to the device or therapy.He would probably call the doctor to see if he could program another bolus because the patient was shaking/withdrawal today and the patient should not be going through withdrawal if the pump still had drug in it and the reporter believed something else was wrong.The expected residual volume (erv) was 7.8 cc and the actual residual volume (arv) was 7 cc which was within specification on (b)(6) 2018.The hcp thought this was a freak incident, that he never heard of this issue before and had been dealing with the pumps for 20 years, for confirming via a print report the pump refill information back on (b)(6) 2018 at the last pump refill, but the pump was at 0mls and alarming.He nor his employees had never been in-serviced about this and would have his company representative (rep) train them.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) indicated the bolus resolved the patient's issues and reprogramming resolved the issues.It was noted they had not seen this problem in the past and they were still unclear what the issue was as they had followed the same protocol as they had the past ten plus years.The cause of the volume discrepancy and "something else wrong with the pump" was unknown.In regard to the cause of the pain, shaking, withdrawal, and not feeling bolus doses it was noted "the pump appeared to have stopped for unknown reasons from our stand point." actions/interventions taken to resolve the event included reprogramming/updating the pump.The event had been resolved and the patient's weight at the time of the event was unknown.No further complications were reported/anticipated or expected.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7570524
• MDR Text Key: 110581528
• Report Number: 3004209178-2018-12636
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Date Device Manufactured: 02/23/2017
• 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 Age: 90 YR