MAUDE Adverse Event Report: MEDTRONICS SYNCHROMEDII

Model Number 8637-20 20ML

Device Problems Break (1069); Computer Software Problem (1112); Nonstandard Device (1420)

Patient Problems Cardiac Arrest (1762); Diarrhea (1811); High Blood Pressure/ Hypertension (1908); Pain (1994); Vomiting (2144); Confusion/ Disorientation (2553)

Event Date 01/02/2017

Event Type  Injury  

Event Description

I am writing on behalf of my mother, (b)(6).She has a medtronic's 8840 synchromediib, model number 8637-20 20ml.Serial number: (b)(4).(b)(6) was taken by ambulance to the er on the above date, but it was only one of a total of 11 times.She was hospitalized on 10 of those occasions since her pump was surgically implanted in (b)(6) 2015.She had her first refill in mid-(b)(6), and had a severe episode soon after that.We have suspected the cause of these episodes to be the intrathecal pain pump, and we have repeatedly asked about (in appointments with the pain doctor and with er and hospital doctors) whether a problem with the pain pump could be the reason for these episodes.Hospital doctors were usually not very knowledgable about these devices, so advised us to follow-up with the pain doctor.At these visits, the doctor denied that the pump could be causing (b)(6) symptoms.At her last hospitalization, the doctors strongly recommended looking at the pain pump as the cause of the episodes.A catheter dye study was ordered by the hospital, and it was discovered that the catheter connector was broken.The broken part was recently repaired in surgery and the medicine amount was cut in half.(b)(6) has not had a pain pump refill since that date, but is due for one in early (b)(6).It appears that there was an fda recall on these pumps in 2013 for this very reason - for a malfunction at the connector.In addition, i just found some new information that there is also a recent recall on her pump for yet another reason - a problem in the computer software.It looks like the fda ordered a class 1 recall, which medtronics issued in september 2016.However, this information was not passed on to us either by medtronics (the company nor by a local representative) or by the pain specialist who inserted the pump and manages it for my mother.Her symptoms have been repeated, severe, and at times life-threatening.They include: severe, intractable vomiting; diarrhea; extremely high blood pressure; all-over pain; and incoherence for several days.(the severe vomiting caused stress to her heart at times, and one time caused a heart attack.) this problem has sent her to the er 11 times since the pump was put in early (b)(6) 2015.Er staff, on 3 occasions, have said her symptoms were like withdrawal/overdose patients they see.The only opioid she receives is morphine through the pump.We have consistently followed-up with the pain doctor after these er visits and hospitalizations, but until our insistence this last time, the catheter dye test to check the delivery of the medicine was not done.We never received any notice or warning regarding either recall, nor did any company technicians contact us after this latest recall, as the fda website, and you in the previous paragraph, stated.It appears the device, medtronics, and the pain specialist who inserted and manages the pump have failed my mother, the patient.

• Brand Name: SYNCHROMEDII
• Type of Device: SYNCHROMEDII
• Manufacturer (Section D): MEDTRONICS
• MDR Report Key: 6521895
• MDR Text Key: 73897917
• Report Number: MW5069327
• Device Sequence Number: 1
• Product Code: LKK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/24/2017

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: No Information
• Device Model Number: 8637-20 20ML
• Device Catalogue Number: 8840
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMITRIPTYLINE; ASPIRIN; ASTELIN; CLOPIDOGREL; EPISODES. ; FLUTICASONE; FUROSEMIDE; HOSPITAL STAYS FOR TREATMENT/PREVENTION OF; ISOSORBIDE; LEVOTHYROXINE; METOPROLOL; MIRALAX.; MIRAPEX; ONDANSETRON; OPC MEDS: VITAMIN B2; PHENERGAM; PROTONIX; REGLAN; REGLAND AND AMITRIPTYLINE WERE PRESCRIBED DURING ; RX MEDS: CPAP; SIMVASTATIN
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 75 YR
• Patient Weight: 75