UK Device Alert Faults Medtronic SynchroMed Supplemental Drug Labeling
This article was originally published in The Gray Sheet
Executive Summary
Medtronic's SynchroMed implantable drug pump poses medication error risk due to an inaccurate listing of intrathecal drugs, an Oct. 31 device alert by the UK's Medical Devices Agency indicates
You may also be interested in...
Medtronic SynchroMed
UK MHRA alert cites five instances of the implantable drug pump malfunctioning following use with diamorphine. While the firm stresses that such use is off-label, the healthcare agency notes the drug was omitted from an updated list of incompatible medications provided by the company last October. Medtronic plans to update the UK list to include diamorphine, which is banned in the U.S. MHRA released a similar alert following the initial pump "Educational Brief," citing inclusion of pump-compatible medications not approved for intrathecal use, as well as other additives that could damage the device (1"The Gray Sheet" Nov. 11, 2002, p. 12) ...
Medtronic SynchroMed
UK MHRA alert cites five instances of the implantable drug pump malfunctioning following use with diamorphine. While the firm stresses that such use is off-label, the healthcare agency notes the drug was omitted from an updated list of incompatible medications provided by the company last October. Medtronic plans to update the UK list to include diamorphine, which is banned in the U.S. MHRA released a similar alert following the initial pump "Educational Brief," citing inclusion of pump-compatible medications not approved for intrathecal use, as well as other additives that could damage the device (1"The Gray Sheet" Nov. 11, 2002, p. 12) ...
UK Medical Devices Agency Alerts NHS Trusts To Notice Format Change
The UK Medical Devices Agency's revised notice format system has four categories corresponding with various levels of severity and appropriate responses