FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1132602
·
Received August 22, 2008
Report
- Report Number
- 3004209178-2008-05188
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 28, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS REMOVED DUE TO INFECTION AT THE PUMP POCKET SITE. THE CATHETER WAS LEFT IN. THE PT WAS STILL HAVING INFECTION ISSUES DUE TO THE CATHETER BEING LEFT IN. THE DRUG CONTAINED IN THE PATIENT'S PUMP WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | IMPLANTED:| CATHETER MODEL 8709SC LOT# N114492012| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED: |