FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 4338294
·
Received December 17, 2014
Report
- Report Number
- 3004209178-2014-24167
- Event Type
- Malfunction
- Date Received
- December 17, 2014
- Report Date
- November 28, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N242539, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. (B)(4).
Description of Event or Problem · 1
THE PATIENT WAS HAVING AN MRI THAT WAS NOT RELATED TO THE PUMP OR THERAPY, BUT THE PATIENT DID STATE THAT THEY DID NOT THINK THE PUMP WAS WORKING. THEY STARTED THINKING THIS TWO DAYS PRIOR TO THE REPORT. THE PUMP CONTAINED BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 827434 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR |