FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2023455
·
Received March 8, 2011
Report
- Report Number
- 3004209178-2011-01724
- Event Type
- Malfunction
- Date Received
- March 8, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 18, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED WITHDRAWAL. SPECIFIC SYMPTOMS OF WITHDRAWAL WERE NOT REPORTED. THE PUMP CONTAINED MORPHINE 50 MG/ML. A CATHETER BLOCKAGE WAS REPORTED; THE BLOCKAGE WAS NOT CONFIRMED. ADDITIONAL TROUBLESHOOTING WAS BEING CONSIDERED. ADDITIONAL INFO HAS BEEN REQUESTED, 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 | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | IMPLANTED:| CATHETER: MODEL 8709, LOT # L74359| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8575, LOT # N165152| EXPLANTED:| CATHETER: MODEL 8596SC, LOT # N181329006| EXPLANTED:| IMPLANTED: |