Medtronic reported that the US Food and Drug Administration (FDA) has classified the corrections being made to product labeling in response to the occurrence of Pocket Fills during a drug refill of a SynchroMed II or SynchroMed EL Implantable Infusion Pump as a Class I recall.
The Class I recall, which is not related to Medtronic external insulin pumps for diabetes, is a situation where there is a probability of occurrence of serious adverse health consequences or death due to the use of the product.
A pocket fill is the inadvertent injection during a refill procedure of all or some of the prescribed drug into the patient’s subcutaneous tissue, which includes the pump pocket (area under the skin where the pump is placed), instead of the pump.
Medtronic determined that pump labeling could be updated to provide additional information to clinicians on using visual and tactile assessments to attain and maintain the appropriate location of the needle throughout the refill procedure.
On 14 January 2011, Medtronic sent an ‘Urgent: Medical Device Correction’ letter to healthcare professionals reminding them of the potential for pocket fills to occur during the SynchroMed II or SynchroMed EL infusion pump refill procedure.
Medtronic is currently updating the labeling for the SynchroMed II and EL pumps and associated refill kits with the information and patient management recommendations from the January 2011 communication.
Medtronic is not retrieving the product from the field or recommending the removal of the product in association with its communication to physicians.