FDA Adverse Event
Other
Summary report: N
SYNCHROMED EL
MDR report key: 358398
·
Received October 25, 2001
Report
- Report Number
- 6000030-2001-00328
- Event Type
- Other
- Date Received
- October 25, 2001
- Report Date
- August 20, 2001
- Manufacturer
- MEDTRONIC INC.
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORT OF EXPLANT OF DEVICE SYSTEM DUE TO "INFECTION" RECEIVED PER ANNUAL DEVICE TRACKING REPORT. FOLLOW UP WITH HCP REVEALED PATIENT HAD ONSET/DIAGNOSIS OF INFECTION IN 2001 AND WAS REPORTED TO HAVE A DIAGNOSIS OF MENINGITIS. THE SYMPTOMS REPORTED INCLUDED REDNESS AND EROSION OVER CATHETER MEDICAL TO PUMP POCKET INCISION. THE PRIMARY LOCATION OF THE INFECTION WAS THE CATHETER TRACK. A CULTURE WAS OBTAINED OF THE DEVICE POCKET AND WAS POSITIVE FOR STAPH AUREUS. THE PT REC'D TREATMENT OF IV ANTIOBIOTICS AND TOTAL SYSTEM EXPLANT. THE INFECTION RESOLVED. THE PT RISK FACTORS INCLUDED DIABETES AND MORBID OBESITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47967 | SYNCHROMED EL | IMPLANTABLE INFUSION PUMP | LKK | MEDTRONIC INC. | 862610 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Hospitalization | EXP: UNK.| CATHETER MODEL 8703W LOT#L82369 IMP: 2000, |