FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2162061
·
Received July 12, 2011
Report
- Report Number
- 3004209178-2011-05358
- Event Type
- Injury
- Date Received
- July 12, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 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
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S DEVICE WAS REMOVED ON (B)(6) 2011. THE PT EXPERIENCED A BOLUS EFFECT WITH PUMP REFILLS. THE EVENT IS ONGOING, HOWEVER, THE PT RECOVERED WITHOUT SEQUELAE. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention | CATHETER: MODEL 8709SC, LOT# UNKNOWN.| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# UNK| IMPLANTED:| EXPLANTED: |