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

Model Number 8637-40

Device Problems Kinked (1339); Aspiration Issue (2883)

Patient Problems Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966); Pain (1994); Sepsis (2067); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8782, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), (b)(6), (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 baclofen at an unknown concentration and dose via an implantable infusion pump.The indication for use was noted to be intractable spasticity.It was reported that the patient believed the catheter was kinking intermittently starting "at least a year" ago relative to (b)(6) 2018.He had been in and out of the hospital with severe spasm attacks every 4-6 weeks.They would check the pump with the "reader" and tell him it was working properly.The patient spoke to the head of neurology department in (b)(6) 2018 who assured him nothing was wrong with the pump "or anything connected to it." the patient then saw his implanting surgeon on (b)(6) 2018 who aspirated the pump and he wasn't getting any spinal fluid back so the patient was told surgery was needed to correct the kink.The revision was scheduled for (b)(6) 2018 but the "patient couldn't make it that long because his condition got really bad over the weekend." he went to the emergency room and they "think he started going through withdrawals because he was in and out." he was transported to a different hospital and had the surgery on (b)(6) 2018.No further complications were reported.

Manufacturer Narrative

Product id: 8782, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a consumer via the legal team reported from the period of approximately (b)(6) 2014 through and including (b)(6) 2018, the patient went to the emergency room on numerous occasions because of severe muscle spasms, always in the lower extremities and sometimes in his midsection and upper extremities.When the patient would travel to the emergency room because of severe muscle spasms, sometimes he would get admitted to the hospital for a number of days, tests would be run, i.V.Medicine would be given to address the muscle spasms and the patient would be subjected to tests and discharged with no diagnosis after tests were "negative" and the muscle spasms subsided.While other times iv medicine would be given to address the muscle spasms and pain.The patient would be discharged with no diagnosis after being held in the emergency room observation area and the muscle spasms would subside.On a number of occasions, the hcp would read the patient's baclofen pump in the emergency room or in the patient's room after being admitted with a handheld reading device and conclude that the baclofen pump was operating normally and not a problem.During one of the admissions into the hospital, the patient was diagnosed with a mini heart attack because the severe spasms caused the patient's heart to race for an extended period of time and the patient's troponin level elevated high enough to cause damage to the patient's heart.During the time period of these severe spasms, the patient was unable to empty their bladder and the retention of urine in the bladder caused multiple infections.Having multiple urinary infections that did not heal contributed to the patient getting sepsis, which is an infection in the bloodstream.The patient almost did not make it through sepsis alive as one point, the patient's blood pressure dropped to 40/25; at another point, the patient could hear questions the doctors were asking but could not speak and give an answer.The patient was in the intensive care unit for approximately 7 days.The patient did not succumb to sepsis.On another occasion, when the was admitted to the hospital after coming into the emergency room because of the severe muscle spasms; the issue of plaintiff's irregular bowel movements came to light and plaintiff ended up having a colostomy.There is a likelihood that the severe muscle spasms caused problems with the patient's bowel movements, which ultimately led to the colostomy procedure.After another emergency room visit due to severe muscle spasms followed by an admission to the hospital, the patient was discharged on saturday, (b)(6) 2018.During this admission, the patient and their family expressed serious concerns to the medical staff that there was something wrong with the baclofen pump and/or the baclofen pump system.Despite these concerns, the hcp completely failed to aspirate the patient's baclofen pump.It was noted that the pump was not aspirated by anyone during any of the patients emergency room visits or subsequent admissions from 2014 through 2018.On (b)(6) 2018, the patient was told there was nothing wrong with the baclofen pump system.The patient contacted the implanting doctor's office and explained their situation to the office.An appointment for pump evaluation was set up for (b)(6) 2019.On that date, the patient's pump was aspirated twice and they did not get any spinal fluid.On (b)(6) 2018, the patient's muscle spasms worsened tremendously and they were admitted to the hospital.The patient's condition worsened and the patient was given iv fentanyl among other drugs to control the muscle spasms and pain.The patient's condition continued to worsen and surgery was performed, on (b)(6) 2018, where the tube was replaced and a new tube was properly placed.It was noted the patient had no muscle spasm outbreaks after the surgery.

• 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: 7531342
• MDR Text Key: 108851195
• Report Number: 3004209178-2018-11423
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2019
• Date Device Manufactured: 12/03/2013
• 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): Hospitalization; Required Intervention