FDA Adverse Event
Other
Summary report: N
SYNCHROMED
MDR report key: 240631
·
Received September 3, 1999
Report
- Report Number
- 9681722-1999-00004
- Event Type
- Other
- Date Received
- September 3, 1999
- Manufacturer
- MEDTRONIC INC
- Product Code
- LKK
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL'S OFFICE STATED THE PT WAS IMPLANTED WITH THE PUMP ON 9/7/1998 AND HAD INFECTION SYMPTOMS NOTED IN HER 9/21/1998 OFFICE VISIT, INCLUDING RIGHT FLANK PAIN, SWELLING, ERYTHEMA, HEADACHE, AND MEGISMUS. ON 9/22/1998, THE PT WAS GIVEN KEFZOL AND GENTAMYCIN IV. CSF FROM THE CATHETER ACCESS PORT SHOWED GLUCOSE AND WBC'S. ON 11/2/1998, THE PT HAD PEDAL EDEMA, FEVER AND CULTURES GREW MYCOBACTERIA FORTUITUM FROM THE ANTERIOR ABDOMINAL WALL AND LUMBAR AREA ABCESS. CIPRO AND BIAZIN WERE GIVEN. IN THE LAST OFFICE VISIT NOTE OF 1/25/1999, THE INFECTION CONTINUED TO BE TREATED WITH ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED Implant | IMPLANTABLE INFUSION PUMP | LKK | MEDTRONIC INC | 861718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | 8703W CATHETER, LOT NUMBER L54364, IMPLANTED| 9/7/1998 EXPLANTED 9/26/1998. |