FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1120752
·
Received August 15, 2008
Report
- Report Number
- 3004209178-2008-04956
- Event Type
- Injury
- Date Received
- August 15, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 18, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS EXPERIENCING NAUSEA AND VOMITING FOLLOWING A NEW PUMP AND CATHETER IMPLANT. A CEREBROSPINAL FLUID LEAK WAS RULED OUT. THE PT WAS ALSO EXPERIENCING A RASH IN 2008, WHICH THE PHYSICIAN THOUGHT WAS A "DILANTIN" RASH. THE PHYSICIAN PLANNED TO WATCH THE PT TO SEE IF THERE WAS A STATUS CHANGE. THE PT WAS ADMITTED TO THE HOSP. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, 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. | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | CATHETER MODEL 8731SC LOT # N126760030| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 8840 LOT # UNK |