FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1162793
·
Received September 16, 2008
Report
- Report Number
- 3004209178-2008-05774
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- January 1, 2008
- Report Date
- August 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS NOT GETTING THE DESIRED RELIEF AND THE HEALTH CARE PROFESSIONAL HAD INCREASED THE DOSE. AN X-RAY WAS DONE AND THE DISTAL SEGMENT OF THE CATHETER WAS FOUND TO HAVE COME OUT. THE DISTAL END WAS REPLACED. THE PATIENT WAS DOING WELL AFTER THE REVISION. THE MEDICATION BEING DELIVERED VIA THE PUMP WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL 8832 LOT# NJG005611N| EXPLANTED| CATHETER MODEL 8703W LOT# L48278 IMPLANTED |