FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1994350
·
Received January 14, 2011
Report
- Report Number
- 3004209178-2011-00368
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- December 21, 2010
- Report Date
- December 21, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- 117
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PUMP STALL WAS NOTED IN THE ATTENTION DIALOGUE BOX; THE NURSE HAD USED A PROGRAMMER MAGNET THINKING IT WAS A SYNC EL PUMP. THE NURSE PLANNED TO RE-INTERROGATE THE PUMP TO SEE IF THE STALL RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT 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 | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Required Intervention | CATHETER: MODEL 8709, LOT# J11376R13.| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11376R13 |