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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Insufficient Flow or Under Infusion (2182)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Neck Pain (2433)

Event Date 08/01/2018

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 patient who was receiving bupivacaine (4 mg/day) and morphine (unknown, 15 mg/day) at an unknown concentration via intrathecal drug delivery pump for spinal pain.It was reported that the patient was having widespread, acute severe pain in their neck, back, chest, left abdomen, left hip, and left testicle.The patient went to the emergency room (er).They found nothing physically wrong, gave the patient some dilaudid and sent them home 'on thursday,' where they remained.The patient was trying to reach their doctor.The target area for the patient's pump therapy was: c4 - c5 (cervical) in neck to t1-t2 (thoracic) - back, shoulders and shoulder blades, arms and hands.The patient had severe pain in his lower back and spine and it had progressively become worse so they went to the emergency room.The pain in their lower extremities had become so bad that it seemed to be aggravating the chronic pain in their upper extremities, and they were experiencing pain in both their upper and lower extremities.When the patient's pain levels increase their blood pressure (bp) increases, so they were prescribed a blood pressure(bp) medication 'last week' which was causing them to have severe headaches and dizziness.The patient had not had any falls or trauma but was completely disabled.The dilaudid from the emergency room and the percocet they were taking were not helping the pain.The patient went to the pain office.The patient was scheduled to see their healthcare provider (hcp) 'this thursday' at 4:30 pm.The hcp was going to change their medication, remove morphine and add dilaudid, and leave the rest as is (bupivacaine and bp medication).The patient would have x-rays performed.The patient was concerned because the pain wasn't getting better and they would have the last appointment on thursday, and the hcp's office was closed on friday.The pain started in their lower back and spine two months ago.Additional information was received from the patient.It was reported that the patient was told to ask about the transition times between medications.The patient was experiencing 24 hour transition time.They did a medication change and they were still hurting severely.When they asked for a printout, the patient was told the healthcare professional (hcp) did not have a printer.The patient had been asking for a printout for 4 months, but they only mailed him out a printout from 2 months back.The patient could not see their alarm dates because they didn't have the printout.The patient was told by the hcp that there were 8 medications in the pump, when there were only supposed to be 3.Hydromorphine, bupivicaine and clonidine were supposed to be in the pump, but the patient was told they also had baclofen, prialt, morphine fulfate, fentanyl, and sufentanyl sulfate.The patient was "floored" by this.It was noted when they pulled out medication from the pump in 23-24 days, they pulled out a full syringe of medication, as well as another quarter (of a syringe) of medication.The syringe was the same size as 20ml.They took out 22-25 ml from the pump, which meant the pump hadn't been on for close to a month; that was why the patient was probably hurting so bad (pump hadn't been on).When the patient asked the hcp, the hcp "got all nervous".The hcp "checked everything" and confirmed this was supposed to be withdrawn from the pump.The pump only holds 20ml.The patient had pump medication changes before, where they changed the pump and the catheter, and the transition period was 2 hours and 6 hours.The patient had made an appointment with a new hcp and would be going back to get their personal therapy manager (ptm) from his current managing hcp.The patient would also be getting the discharge papers from the current hcp.The patient had gotten 13 years of pain relief with the pump, but with these issues they were currently having, it was like they were taking steps back.No further complications were reported.

• 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: 8101704
• MDR Text Key: 129082450
• Report Number: 3004209178-2018-26162
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/26/2018

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: 06/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/26/2018
• Date Device Manufactured: 01/07/2015
• 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 Age: 57 YR