SYNCHROMED II
Report
- Report Number
- 3007566237-2012-02588
- Event Type
- Injury
- Date Received
- October 31, 2012
- Report Date
- October 3, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER ¿KINKED AND BROKE¿ AND THE PATIENT DEVELOPED SPINAL FLUID HEADACHES. SHE WAS UNABLE TO GET TO HER NEEDED REHAB. IT WAS NOTED THAT THE PATIENT WAS VERY ACTIVE, AND THAT COULD BE THE CAUSE OF CATHETER ISSUES.
IT WAS REPORTED THAT PATIENT EXPERIENCED DECREASED THERAPEUTIC BENEFIT OR PRESENTED WITH VISIBLE SIGNS AND/OR SYMPTOMS OF DECREASED THERAPEUTIC BENEFIT. BEGINNING (B)(6) 2011, THE PATIENT BEGAN EXPERIENCING INCREASED STIFFNESS. VERIFICATION OF PUMP CONTENTS, ADJUSTMENT OF DOSING AND CATHETER ACCESS PORT (CAP) ASPIRATION WERE ALL COMPLETED WITH NO IMPROVEMENT OF PATIENT SYMPTOMS. THE PATIENT HAD X-RAYS COMPLETED IN OCTOBER AND A SPIRAL CT COMPLETED ON (B)(6) 2011. THE CT SCAN WAS SIGNIFICANT FOR A CATHETER LEAK. THE PUMP AND CATHETER WERE REPLACED ON (B)(6) 2012. THE PATIENT IMPROVED AFTER THE REVISION. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.
IT WAS LATER REPORTED IT WAS A CATHETER BREAK IN THE PERIPHERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |