Recall Z-0788-2017 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the followi
| Date | Dec 19, 2016 (initiated Oct 3, 2016) |
| Status | Terminated |
| Reason | Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue. |
| Root cause | Under Investigation by firm |
| Action | Medtronic Representatives began visiting consignees on 10/3/2016 to replace previous version Model 8870 software application cards, contained within the model 8840 N Vision Clinician Programmer, with the updated version (new version is AAU01). Beginning October 20, 2016, Implanting and Following physicians were sent an Urgent Medical Device Correction letter dated September 2016, . This letter to physicians is informing them of the updated Model 8870 software application card, and changes to SynchroMed infusion system labeling. A response form is requested to be returned to Medtronic. Cus |
| Quantity | 22,298 software cards |
| Distribution | Worldwide Distribution - (US Nationwide) Internationally to Germany, Greece, Australia, United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.