FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2172596
·
Received July 20, 2011
Report
- Report Number
- 3004209178-2011-05614
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 28, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT SUSPICIOUS FLUID WAS IN THE DEVICE POCKET; AND THE PT'S FULL DEVICE SYSTEM WAS EXPLANTED. THE DEVICE WAS USED TO DELIVER BACLOFEN, DOSE UNK. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT# N109239034 |