FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202662
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-02794
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- May 23, 2012
- Report Date
- May 23, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S DRUG PUMP RESERVOIR WAS EMPTY AND AN ALARM WAS SOUNDING. PATIENT WAS HAVING DIFFICULTY LOCATING AN HCP TO REFILL THE PUMP. THE DRUG DELIVERED BY THE IMPLANTABLE SYSTEM WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302801 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00035 YR |