FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2180966
·
Received July 22, 2011
Report
- Report Number
- 3004209178-2011-05660
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- April 1, 2011
- Report Date
- June 1, 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
- DE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD LOSS OF THERAPY. THERE WAS EXCESS MEDICATION IN RESERVOIR WITH SUSPECTED PUMP FLIP AND TWISTED CATHETER. THE DEVICE WAS USED TO RENDER MEDICATION FOR PAIN.
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 | 56 YR | Required Intervention | IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N220639011| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N245980| EXPLANTED: |