FDA Adverse Event
Other
Summary report: N
SYNCHROMED
MDR report key: 260813
·
Received February 1, 2000
Report
- Report Number
- 6000030-2000-00023
- Event Type
- Other
- Date Received
- February 1, 2000
- Date of Event
- November 24, 1999
- Report Date
- December 8, 1999
- Manufacturer
- METRONIC INC.
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT'S INFECTION MANIFESTED AT ABOUT 2 MONTHS POST IMPLANT. PT WAS TREATED FOR THE INFECTION BUT THE DEVICE WAS EVENTUALLY EXPLANTED. PT HAS A HISTORY OF MANY INFECTIONS AND WAS REFERRED TO INFECTIOUS DISEASE CONTROL FOR MANAGEMENT. PT RECOVERED FULLY FROM THIS INFECTION AND HAS WAITED 6 TO 8 MONTHS POST INFECTION AND HAS BEEN SUCCESSFULLY REIMPLANTED WITH A NEW DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | IMPLANTABLE INFUSION PUMP | LKK | METRONIC INC. | 861718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization | 1999, EXPLANTED IN 1999.| CATHETER MODEL 8703W, LOT# L57665, IMPLANTED IN |