FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3872321
·
Received June 13, 2014
Report
- Report Number
- 3004209178-2014-11562
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Report Date
- May 16, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008,PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT, AT THE END OF SUMMER LAST YEAR, A REFILL WAS MISSED. THE PATIENT EXPERIENCED EXTREME BODY ACHES, EXTREME PAIN AND ALWAYS HAD STOMACH PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349189 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR |