FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2181288
·
Received July 21, 2011
Report
- Report Number
- 3004209178-2011-05646
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 30, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD TEMPERATURES OF 89 AND 101 DEGREES, UNSTABLE BLOOD PRESSURE, "UNLEVEL" EYES, AND OTHER ISSUES. THE PATIENT WAS IN ICU WHEN THE EVENT WAS REPORTED. THE ISSUES BEGAN WHEN THE PATIENT HAD A CATHETER IMPLANTED AT C1. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Hospitalization | EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N263126008| CATHETER: MODEL 8711, LOT# N247279007 |