Problems with Medtronic Intrathecal Catheters (Dec. 2008)

Medtronic has alerted healthcare professionals about the potential for misconnections between certain sutureless intrathecal catheters and the implanted infusion pumps to which they're attached. The four affected products are:

• INDURA 1P Intrathecal Catheter, model 8709SC

• Intrathecal Catheter, model 8731SC

• Sutureless Pump Connector Revision Kit, model 8578

• Intrathecal Catheter Pump Segment Revision Kit, model 8596SC

The affected catheters are used in conjunction with implanted Medtronic infusion pumps to deliver medications directly to the intrathecal space in the spine. They are used primarily to treat chronic, intractable pain and severe spasticity. The affected pumps are the SyncroMed II, SyncroMed EL and IsoMed. This action does not include Medtronic MiniMed infusion pumps.

The company says it has received reports of misalignment or incomplete connection between the sutureless pump connector and the catheter port. This can cause the catheter to disconnect from the infusion pump, or it can cause an occlusion between the catheter and the pump. In either case, the patient can experience severe underdosing. In those receiving baclofen, this can result in a withdrawal syndrome that can be fatal.

Medtronic is stressing the importance of using proper techniques when connecting the pump and catheter. This includes verifying that there is backflow of CSF through the catheter, ensuring that the sutureless connector and the pump are aligned, snapping the sutureless connector to the pump firmly, and tugging on and rotating the connection to be sure the attachment is secure.

The firm also recommends that patients and caregivers be educated to recognize the symptoms of drug underdose and withdrawal and to seek immediate medical assistance. Clinicians should keep in mind that patients who have had intrathecal therapy interrupted may be drug naïve when the therapy is resumed and so may need an adjustment in dosage.

Category:

Education

Tags:

• Medtronic
• Intrathecal
• Catheters
• FDA
• Misconnections
• Infusion
• Pumps
• SyncroMed
• II
• EL
• IsoMed
• Patient
• Safety

[isisncasey]

Here in the US you have a hard time suing the doctor for medical malpractice. You have to PROVE it yourself.

[rael8]

no, not really. you get use to it being in your body and tend to forget about it being there. it really reduces the pain alot better than almost every pain medication that i was put on in the last 5 years. no, i don't get any side effects at all. it is like i am on nothing. meds go right to the spinal cord an that is all. damn lol. get my first refill next week. kinda freaked out about that. lets be friends on facebook and i can keep you updated.

[tpvalley]

@rael8

doesnt it freak u out having a pipe in ur spine, and do u get same effects as normal IV painkillers, drowsey, euphoria etc?

[tpvalley]

@isisncasey

I hope u reported him to correct authorities?

or do u have to pay to do that in usa?

we get legal aid in UK, this prevents the rich getting away with murder.

[rael8]

@tpvalley an oclusion is some sort of kink in the works usually in the line. the line gets bent, loose, misalignment or something like that. i have one of these. i just got it in december of 2010. i get my first refill next week in february.

[tpvalley]

whats an oclusion.?

[kirafaye]

Wow thats insane he would let you go dry its so freaking dangerous to do that!

[isisncasey]

We caught my doctor trying to scam my insurance company by forcing me to re-fill every 2 weeks for 6 months. Aftet objecting he refused to re-fill my pump at all. My pump was dry for 5 days. 5 days of

HELL. Beware of Dr Chavin in Morristown TN