FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202359
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-01031
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- April 20, 2012
- Report Date
- April 20, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, SERIAL# (B)(6), IMPLANTED: 2004 (B)(6); PRODUCT TYPE CATHETER. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF EFFICACY. THE PATIENT WAS HAVING A DYE STUDY TO TRY TO IDENTIFY THE PROBLEM. IT WAS SUSPECTED THAT THE CATHETER MAY HAVE BEEN KINKED. ADDITIONAL INFORMATION 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 |
|---|---|---|---|---|---|---|---|
| 301858 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR |