FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1132593
·
Received August 22, 2008
Report
- Report Number
- 3004209178-2008-05156
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- August 20, 2007
- Report Date
- July 24, 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULT CODE OTHER: CATHETER.
Description of Event or Problem · 1
PT DEVELOPED A "BUMP" (LOCATION NOT SPECIFIED), IT WAS ASPIRATED SEVERAL TIMES. IT WAS DETERMINED THERE WAS A CEREBROSPINAL FLUID LEAK AT THE INTRATHECAL SECTION. THE CATHETER WAS REPLACED. THE PUMP WAS USED TO DELIVER MORPHINE SULFATE (5.0 MG/ML AT 0.3965 MG/DAY). THE PT RECOVERED WITHOUT SEQUELAE.
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 | 71 YR | Required Intervention | IMPLANTED| PROGRAMMER MODEL 8840| IMPLANTED| CATHETER MODEL 8709| EXPLANTED |