FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2212657
·
Received August 11, 2011
Report
- Report Number
- 3004209178-2011-06250
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 20, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S ENTIRE CATHETER WAS EXPLANTED. THE PATIENT HAD A NEW CATHETER PLACED. THE PATIENT HAD A ONE-PIECE BEFORE, IT WAS COMPLETELY DISLODGED AND FELL OUT OF THE INTRATHECAL SPACE AND COILED UP THE SPINE. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention | CATHETER: MODEL 8709SC, LOT # N223478005| IMPLANTED:| EXPLANTED: |