FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1003436
·
Received February 21, 2008
Report
- Report Number
- 3004209178-2008-00845
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- January 24, 2008
- Report Date
- January 24, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE HCP REPORTED THAT, AT IMPLANTATION, THERE WAS PASSIVE CEREBROSPINAL FLUID BACKFLOW THROUGH THE CATHETER; HE WAS ALSO ABLE TO FLUSH WATER THROUGH THE CATHETER ACCESS PORT PRIOR TO CONNECTING THE CATHETER TO THE PUMP. HOWEVER, AFTER CONNECTING THE CATHETER TO THE PUMP, THE HCP HAD DIFFICULTY ASPIRATING FLUID THROUGH THE CATHETER ACCESS PORT. THE PUMP REMAINS IMPLANTED. NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE. 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. | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | EXPLANTED:| CATHETER MODEL 8731SC| PROGRAMMER MODEL 8840| IMPLANTED:| EXPLANTED: |