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FDA Issues Pain Pump Recall

If you are experiencing pain and you’re getting little relief from your medication, your doctor may prescribe a drug pain pump.  These implantable devices send pain medication directly to the area of trauma providing pain relief with a small fraction of the medication needed if taken orally.  A painkiller taken in pill form, in contrast, would first have to be digested, absorbed into your system and circulate around your entire body.  A pain pump is a highly targeted delivery system such that doctors can prescribe less medication which lowers your drug cost. These pain pumps are used to deliver pain medications to the spinal column to treat chronic pain as well as treat pain in cancer patients.

One manufacturer of pain pumps, Medtronic has had a number of problems with their pain devices that have generated a Medtronic Pain Pump Warning followed by a Pain Pump Recall.

Medtronic Pain Pump Warning Issued

A Medtronic Pain Pump Warning has been issued for medications and device attachments that contain neurotoxic preservatives, antimicrobials, or antioxidants, or may be incompatible with the device and can damage the system.  Failure to comply with all product instructions, including use of drugs or fluids not indicated for use with Medtronic systems or of questionable sterility or quality, or use of non-Medtronic components or inappropriate kits, can result in improper use, technical errors, increased risk to patient, tissue damage, damage to the system requiring revision or replacement, and/or change in therapy, and may result in additional surgical procedures or generate fatal drug under or overdoses.

The Medtronic Pain Pump Warning also states that a seroma pocket or inflammatory mass can result in serious neurological damage, including paralysis which may occur at the tip of the implanted catheter.  Medtronic tells physicians that they need to monitor patients on intraspinal therapy carefully for any new neurological symptoms, change in underlying symptoms, or need for changes in pain dosages.  The Medtronic Pain Pump Warning also tells physicians that they need to instruct patients to notify other doctors that they have an implanted pump before any medical procedures are done.  Patients also need to know to return for refills at prescribed times, to carry their Medtronic device identification card, to avoid manipulating the pump through the skin, to consult their doctor if the pump alarms and before traveling or engaging in activities that can stress the infusion system or involve pressure or temperature changes.  Given that there has been a Pain Pump Recall, you might want to contact a pain pump lawyer to inquire about your legal rights and to learn more about the Medtronic Pain Pump Warning.

Medtronic pain pump side effects include spinal and vascular complications such as infection, bleeding, tissue damage, all of which may require additional surgical procedures.  Pocket seroma (fluid filled sac), hematoma, infection, lumbar puncture, meningitis, paralysis and device rejection can occur with improper use of the pump.  Given that a Medtronic Pain Pump Warning and Pain Pump Recall have been issued, lawsuits are being filed around the country.  If you have experienced pump side effects you may want to consult with a pain pump lawyer to discuss your legal rights in this matter.

Due to all these complications a Medtronic Pain Pump Warning was initiated by the FDA warning physicians and consumers about the numerous problems with this implant.  The Medtronic Pain Pump Warning has now become a Pain Pump Recall in 2008.  The FDA has classified this alert as a Class I Pain Pump Recall.  The FDA realizes that use of this product may cause serious adverse health consequences or death.  Neither the FDA nor Medtronic require that the pump be removed from patients.  However, they recommended that patients who have the Pain Pump Recall be monitored closely.

The Medtronic Pain Pump Recall includes models:

  • 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

You May be entitled to Compensation, so act now.

Lawyer are now speaking with individuals who have been harmed after receiving a shoulder pain pump after surgery. According to the FDA some  injections given by infusion pain pumps has resulted in reports of chondrolysis,  a severe type of shoulder arthritis in which the cartilage of the joint is abruptly lost after shoulder arthroscopy.

If you or a loved one has been injured as a result of a Medtronic Pain Pump installed in your shoulder, contact us now to speak with our qualified professionals about possible compensation.  Call us now at 877-222-7069 or use the contact form for a free case review.

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