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overdoses and device failures
Carabin Law is investigating injuries linked to the Medtronic SynchroMed II pain pump, an implanted drug delivery device designed to administer medication directly into the spinal fluid. The device has been used to treat patients suffering from cancer pain, severe muscle spasms, and chronic pain conditions.
Although approved by the FDA, the SynchroMed II has been associated with serious design and safety problems. Reports allege that device malfunctions can cause patients to receive too much medication, too little medication, or no medication at all, each of which can lead to severe and life-threatening outcomes.
SynchroMed II Design Defects and Safety Issues
Two primary defects have been identified in connection with the SynchroMed II pain pump:
Pocket fill errors, which may occur during refills when medication is unintentionally injected into the tissue beneath the skin rather than into the pump, potentially causing overdose or death
Battery failures, which may result in underdosing, sudden loss of pain control, or dangerous drug withdrawal symptoms
Both defects have been linked to emergency medical events and long-term patient harm.
FDA Action and Reported Injuries
Following multiple inspections, federal regulators identified ongoing manufacturing and quality-control violations at Medtronic facilities. After years of unresolved issues, the FDA restricted Medtronic’s ability to manufacture and distribute the SynchroMed II until compliance requirements were met.
According to reports, the device has been linked to numerous adverse events, including serious injuries and patient deaths.
Injured? Contact Carabin Law
If you or a loved one experienced complications after receiving a Medtronic SynchroMed II pain pump, you may have legal options. Carabin Law represents individuals injured by defective medical devices and handles complex mass tort cases across Texas.
Contact Carabin Law today for a FREE, confidential case review.