SYNCHROMED
Report
- Report Number
- 3007566237-2013-01608
- Event Type
- Injury
- Date Received
- May 14, 2013
- Report Date
- April 16, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 8731SC, LOT # UNKNOWN, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
ANALYSIS OF THE CATHETER AND SC CONNECTOR REVEALED INDENT IN SEAL AND OCCLUSION RELATED ISSUE. DURING PATENCY TESTING, OCCLUSION OCCURRED INTERMITTENTLY. UNDER MICROSCOPE INSPECTION CIRCULAR CORING CAN BE SEEN IN THE BOTTOM OF THE CUP OF THE SC CONNECTOR CONSISTENT WITH THE INNER DIAMETER OF THE TIP OF THE OUTLET PORT OF THE PUMP. A MAJORITY OF THE CORING AREAS IS LOCATED IN THE SEAL MATERIAL OF THE CUP OF THE SC CONNECTOR. IT IS THOUGHT THE SC CONNECTION TO THE PUMP WAS INITIALLY PATENT BUT AS CORING OCCURRED, THE FLAP OF MATERIAL THAT WAS CREATED BEGAN TO CAUSE AN OCCLUSION.
THE CATHETER WAS EXPLANTED ON (B)(6) 2013. THE PATIENT STATUS WAS ALIVE, NO INJURY, NO ADVERSE EVENT. THE PUMP WAS DELIVERING LIORESAL.
IT WAS REPORTED THE CATHETER WAS EXPLANTED FOLLOWING SUSPICION OF OCCLUSION, "TWO OR THREE" MONTHS AGO. THE CATHETER AND PUMP WERE IMPLANTED "SEVEN OR EIGHT" MONTHS AGO. THE CATHETER WAS SAID TO BE "CAPPED/ABANDONED/PARTIALLY REMOVED." THE PATIENT HAD SYMPTOMS OF INCREASED SPASTICITY.
FOLLOWING THE CATHETER REPLACEMENT, THE PATIENT WAS ¿OK¿ AND RECEIVING EFFECTIVE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212566 | SYNCHROMED | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |