Recall Z-1060-2011 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic, Inc. - Neuromodulation
Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: " Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain Preservative-free sterile saline, USP, ca
| Date | Feb 10, 2011 (initiated Jan 14, 2011) |
| Status | Terminated |
| Reason | This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations that will be added to our product labeling. A pocket fill is the inadvertent injection of all or some of the prescribed drug into the patients subcutaneous tissue, which includes the pum |
| Root cause | Other |
| Action | The firm, Medtronic, sent an "Urgent Medical Device Correction Cover " letter dated January 2011 to all customers. Enclosed with each letter, an "Urgent Medical Device Correction Important Clinical Information about Pocket Fills" letter dated January 2011 as well as a Clinician Refill Reference Card, Refill Appointment Cards, Physician Reply Card and a Self Addressed Stamped Envelope. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to always check the needle placement within the pump septum throughout the procedure to help p |
| Quantity | 91,369 total for all devices. |
| Distribution | Worldwide distribution: USA including DC and PR and countries including: AUSTRALIA, NEW ZEALAND, HONG KONG, TAIWAN, CHINA, SINGAPORE, MALAYSIA, INDONESIA, SOUTH KOREA, THAILAND, ARUBA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, D |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.