FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1940370
·
Received December 20, 2010
Report
- Report Number
- 3004209178-2010-10600
- Event Type
- Injury
- Date Received
- December 20, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 8, 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
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT WAS BROUGHT INTO THE OPERATING ROOM FOR A POCKET REVISION DUE TO A FLIPPED PUMP. UPON OPENING THE POCKET, AN INFECTION WAS NOTED. THE ENTIRE DEVICE SYSTEM WAS EXPLANTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT 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 | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | CATHETER: MODEL 8709SC, LOT #: N257172009| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8578, LOT #: N252818009| EXPLANTED:| EXPLANTED: |