FDA Adverse Event
Other
Summary report: N
SYNCHROMED EL
MDR report key: 406663
·
Received July 22, 2002
Report
- Report Number
- 6000030-2002-00525
- Event Type
- Other
- Date Received
- July 22, 2002
- Manufacturer
- MEDTRONIC INC.
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTED THE PT WAS DIAGNOSED WITH AN INFECTION OF THE DEVICE POCKET ON 03/2002. THE PT HAD SYMPTOMS OF REDNESS AND PAIN. A CULTURE OF THE DEVICE POCKET WAS POSITIVE FOR MRSA. THE PT WAS TREATED WITH BOTH IV AND ORAL ANTIBIOTICS. THE PUMP WAS NOT REMOVED, IT WAS STOPPED, AND THE PT WAS BEGUN ON ORAL MEDICATION. THE INFECTION RESOLVED AND THERE WAS NO DRUG WITHDRAWAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | IMPLANTABLE INFUSION PUMP | LKK | MEDTRONIC INC. | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other | EXPLANTED: UNK.| CATHETER: MODEL 8703W LOT# L54367 IMPLANTED: 1998, |