FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1953546
·
Received January 5, 2011
Report
- Report Number
- 3004209178-2011-00058
- Event Type
- Injury
- Date Received
- January 5, 2011
- Date of Event
- July 1, 2009
- Report Date
- December 10, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PUMP AND CATHETER WERE REMOVED ABOUT THREE DAYS AFTER IMPLANT, BECAUSE OF INFECTION/MENINGITIS. 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 | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | CATHETER: MODEL 8731SC, LOT# N197152018| IMPLANTED:| EXPLANTED: |