FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1150249
·
Received September 3, 2008
Report
- Report Number
- 3004209178-2008-05408
- Event Type
- Injury
- Date Received
- September 3, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 5, 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
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT COMPLAINED OF HEADACHES AND POOR PAIN RELIEF. A DYE STUDY WAS PERFORMED AND THE HCP WAS UNABLE TO ASPIRATE ANY CSF. RESIDUAL VOLUMES WERE FOUND TO BE NORMAL. THE PT HAD A REVISION. NO FURTHER OUTCOME WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | IMPLANTED| EXPLANTED| CATHETER MODEL 8709SC LOT# N111552022| PROGRAMMER MODEL 8840 LOT# UNK |