FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2900388
·
Received January 7, 2013
Report
- Report Number
- 3004209178-2013-00270
- Event Type
- Injury
- Date Received
- January 7, 2013
- Report Date
- December 11, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6). (B)(4).
Description of Event or Problem · 1
CATHETER MIGRATION WAS REPORTED. IT WAS STATED THAT THE CATHETER WITHDREW FROM THE INTRATHECAL SPACE, THE ANCHOR REMAINED INTACT, THE MIGRATION WAS THUS DISTAL TO THE ANCHOR. THE DISTAL PORTION OF THE CATHETER WAS TRIMMED AND REMOVED. THE SPINAL SEGMENT WAS USED TO RECONNECT THE EXISTING CATHETER TO THE INTRATHECAL SPACE. PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF. PATIENT STATUS AT TIME OF THIS REPORT WAS STATED AS ALIVE NO INJURY/NO ADVERSE EVENT. DRUGS DELIVERED VIA THE DEVICE WERE INFUMORPH, AND CLONIDINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6285 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |