SYNCHROMED
Report
- Report Number
- 3007566237-2011-02719
- Event Type
- Injury
- Date Received
- April 11, 2011
- Report Date
- July 29, 2025
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4).
ON (B)(6) 2011, THE PT WAS ADMITTED TO THE HOSPITAL FOR AN ELECTIVE CATHETER MYELOGRAM IN ORDER TO ENSURE PATENCY AND CONTINUITY OF CATHETER. THE RESULTS OF THE PROCEDURE WERE INCONCLUSIVE; HOWEVER, X-RAYS AT THE TIME SHOWED A POTENTIAL DISCONNECT BETWEEN THE PUMP AND THE CATHETER OVER THE JUNCTION SITE. THE CONSULTANT ARRANGED FOR FURTHER X-RAYS WHICH WERE TAKEN ON (B)(6) 2011. THESE IMAGES SHOWED A CLEAR DISCONNECTION BETWEEN THE PUMP AND CATHETER. ARRANGEMENTS WERE UNDER WAY TO ADMIT THE PT FOR CATHETER REVISION AND RECONNECTION AS SOON AS POSSIBLE. THE SEVERITY OF THE EVENT WAS NOTED TO BE "SEVERE". IT WAS NOTED THAT IT WAS UNK WHEN THE DISCONNECTION OCCURRED; IT WAS THOUGHT THAT THE PT HAD NOT BEEN RECEIVING ANY INTRATHECAL ANALGESIA FOR A WHILE. THE PT HAD HAD NEW PAINS, A PROBLEM WITH MEMORY, AND REDUCED ABILITY TO CONCENTRATE SINCE (B)(6) 2009 AND INSOMNIA SINCE (B)(6) 2010; ALL WERE NOTED TO BE "NOT RESOLVED". THE DEVICE SYSTEM WAS USED TO DELIVER CLONIDINE, MORPHINE, AND PRIALT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization | CATHETER MODEL 8731SC| CATHETER: MODEL CATHETER, LOT # UNKNOWN| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT # UNKNOWN| EXPLANTED: |