FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2211074
·
Received August 5, 2011
Report
- Report Number
- 3004209178-2011-06105
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Report Date
- July 18, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS TO BE REPLACED DUE TO A "CONNECTION ISSUE": CATHETER AND PUMP DISCONNECTED. NO PUMP ALARMS WERE HEARD. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED INFUSION PUMP: MODEL 8637-20,| LOT #NGP031457N| IMPLANTED:| EXPLANTED.| CATHETER: MODEL 8709, LOT #N141385030| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT #N203714| EXPLANTED:| IMPLANTED: |