FDA Adverse Event
Other
Summary report: N
SYNCHROMED EL
MDR report key: 521175
·
Received April 16, 2004
Report
- Report Number
- 6000030-2004-00498
- Event Type
- Other
- Date Received
- April 16, 2004
- Date of Event
- March 30, 2004
- Report Date
- April 12, 2004
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE ENTIRE DEVICE SYSTEM WAS EXPLANTED IN 2004 DUE TO AN INFECTION. A NECROTIZED ABDOMINAL WOUND, AND THE PUMP BEING VISIBLE DUE TO A WOUND DEHISCENCE. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFO IS RECEIVED.
Description of Event or Problem · 1
ADD INFO FROM THE HAP THE HCP REPORTES THE PT PRESENTED WITH REDNESS, SWELLING, DRAINAGE, AND INCISIONAL WOULD OPENING OF THE DEVICE POCKET. A CULTURE OF DEVICE POCKET WAS POSITIVE FOR E.FAECALIS. THE PT DID NOT HAVE MENINGITIS. THE PT WAS TREATED WITH IV ANTIBIOTICS. THE INFECTION REPROTED TO HAVE RESOVED AND THE PT OUT COME IS ONGOING. THE PT HAS RISK FACTORS OF DEBILITATED STATUS AND DECUBITUS ULCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP | LKK | RICE CREEK MFG | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other | IMPLANTED: 2004,| EXPLANTED: 2004.| CATHETER MODEL 8709AA, LOT# J11643R28, |