FDA Adverse Event
Other
Summary report: N
SYNCHROMED II
MDR report key: 648962
·
Received December 2, 2005
Report
- Report Number
- 2182207-2005-01875
- Event Type
- Other
- Date Received
- December 2, 2005
- Date of Event
- November 22, 2005
- Report Date
- November 22, 2005
- Manufacturer
- NEUROLGOICAL DIV, MEDTRONIC, INC.
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE MFR'S REP REPORTED THE PUMP AND CATHETER WERE EXPLANTED, DUE TO INFECTION. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFO IS RECEIVED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION FROM THE HCP REPORTS THE PATIENT PRESENTED ON 11/21/2005 WITH REDNESS, SWELLING, AND PAIN OF THE DEVICE POCKET AND CATHETER TRACK. CULTURES OF BOTH THE DEVICE POCKET AND THE LUMBAR REGION WERE DONE. THE RESULTS WERE NOT REPORTED, BUT IT WAS KNOWN THAT THE PT DID NOT HAVE MININGITIS. THE PATIENT WAS TREATED WITH BOTH IV AND ORAL ANTIBIOTICS AND TOTAL DEVICE SYSTEM EXPLANT. THE PT OUTCOME WAS REPORTED AS ONGOING WITH NO DRUG WITHDRAWAL. THE PT HAD NO KNOWN RISK FACTORS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP | LKK | NEUROLGOICAL DIV, MEDTRONIC, INC. | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization| O |