FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3232892
·
Received July 18, 2013
Report
- Report Number
- 3004209178-2013-11946
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- January 1, 2012
- Report Date
- August 23, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8711, LOT# N122996004, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN MRI PERFORMED IN 2012 THE PATIENT¿S PUMP ¿KIND OF FELT WARM INSIDE.¿ THE MRI WAS PERFORMED FOR MEDICAL ISSUES UNRELATED TO THE DEVICE SYSTEM. THE PUMP DID NOT CONTAIN MEDICATION AT THIS TIME AND HAD NOT DELIVERED THERAPY SINCE DECEMBER, 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334208 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR |