FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3864323
·
Received June 10, 2014
Report
- Report Number
- 3004209178-2014-11299
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 19, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE PUMP FOUND NO ANOMALY.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS DIFFICULTIES WITH FILLING. IT WAS NOTED THAT THEY COULD NOT PUSH ANYTHING IN AND COULD ONLY GET OUT 10CC WITH EXTREME DIFFICULTIES. IT WAS NOTED THAT THE DEVICE WAS NEVER IMPLANTED A DIFFERENT PRODUCT WAS USED. THE PUMP WAS GOING TO BE USED TO DELIVER GABLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339416 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |