FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1890192
·
Received October 22, 2010
Report
- Report Number
- 3004209178-2010-08284
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 27, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A PUMP PROBLEM. THERE WAS A CONFIRMED REPORT OF A FLIPPED PUMP. 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 | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | EXPLANTED:| CATHETER: MODEL 8709SC, LOT # N232615001| IMPLANTED: |