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

Model Number 8637-40

Device Problems Kinked (1339); Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2002, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4) , ubd: (b)(4) 2004, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving intrathecal clonidine, bupivacaine, and unknown morphine (unknown concentrations and doses) via an implanted pump for spinal pain. It was reported the healthcare provider (hcp) had said the catheter had been in the wrong place and the patient had her catheter moved and changed last year. The patient wanted to know how the doctor knew it was in the wrong place. It was reported after the revision was completed, her hcp told her he had removed a golfball sized tumor where her catheter went into her spine and the catheter he took out had a kink in it. Since it was replaced it had been better, it was targeting the pain area, and she has had improvement. The event date was (b)(6) 2017 and the patient was to follow up with the hcp. It was reported the patient got the pain pump for lower back pain after an accident. She guessed she used to be on a really high dose of medication (she was supposed to be getting pain relief from a humongous dose) since prior to the catheter change. The patient was now on 40% of what she used to be on. The patient¿s hcp retired in 2016, then she started working with a new doctor who asked her where do you hurt and she said ¿everywhere!¿ finally, at her last refill it said 10 or 11 cc and the patient said, this was not right. The patient insisted, and they did an x-ray. The patient said after that they called her with 2 days¿ notice they were going to change the catheter. The patient asked the nurse where the medication was going prior to the catheter revision and the nurse told her the medication was going to her kidneys, they did not know how much was going to her kidneys. It was also reported from the patient¿s knees down it felt like she was walking in quicksand. This was going on since prior to the surgery. Additionally, it was noted the patient started going downhill in 2008 and she was used to it (pain). The patient also reported later it hurts everywhere and put an event date on it of "the mid 2000s. " additional information was received via a consumer. It was reported that the patient received a report from the hcp which said that their pump had not been working in a long time. It was indicated that this was the exact wording and the patient wondered how that can happen when its checked and monitored. It was further reported that the patient was questioning if the hcp would know if the pump was working or not. The patient wondered if there was anything on the pump to tell the physician it¿s not working. Possible scenarios when pump would alarm were being considered at the time of the report. It was indicated that the only time if ever it alarmed was when the pump was low on medication. The patient stated that nothing is going on with the pump and a request for further information was declined by the reporter. It was further noted however that the patient was asking before the catheter change out which was (b)(6) 2017. The (b)(6) 2017 date regarding the catheter procedure conflicts with previously reported information of having been 2017-sep-20. The patient was wondering if it can take 48 hours when getting the pump turned up, which was mentioned as having been something someone in the hcp¿s office said. Regarding reported symptoms, it was stated that the pump was not working. The reporter was considering talking with the hcp about their questions. The reporter was directed to the hcp. No further complications were reported/anticipated or expected.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7338984
• MDR Text Key: 102387651
• Report Number: 3004209178-2018-05014
• Device Sequence Number: 1
• Product Code: LKK
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/14/2018 Patient Sequence Number: 1