FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1032142
·
Received April 21, 2008
Report
- Report Number
- 3004209178-2008-02121
- Event Type
- Injury
- Date Received
- April 21, 2008
- Date of Event
- January 1, 2008
- Report Date
- March 26, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN 2008, THE PATIENT'S PUMP WAS MOVED TO THE OTHER SIDE DUE TO DISCOMFORT IN THE PREVIOUS LOCATION. FOLLOWING THE REPOSITIONING OF THE DEVICE, THE PT DEVELOPED AN INFECTION AND THE PUMP WAS REMOVED. THE PT WAS SEEN THREE MONTHS LATER AND WAS REPORTED TO BE DOING WELL. THE PUMP WAS USED TO DELIVER FENTANYL, CLONIDINE, AND COMPOUNDED BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER: MODEL 8709SC, LOT # N123195007| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT # UNK |