FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202861
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-04621
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- September 26, 2012
- Report Date
- March 11, 2013
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NON-CRITICAL ALARM WAS SOUNDING DUE TO A LOW DRUG PUMP RESERVOIR VOLUME. THIS OCCURRED DURING A HOSPITAL ADMISSION FOR PNEUMONIA. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302584 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR |