FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3200053
·
Received July 1, 2013
Report
- Report Number
- 3004209178-2013-04873
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Report Date
- March 29, 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
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2001-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8832, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE RETURN OF PAIN DURING ONE LONG FLIGHT TO (B)(6). THE PAIN WORSENED AFTER LANDING. THE PATIENT HAD SEVERAL FLIGHTS WITHIN (B)(6), AND IT WAS NOTED THAT EACH TIME THE PATIENT WOULD HAVE ¿TOTAL RETURN OF PAIN¿ AFTER LANDING. THE PUMP WAS CHECKED 2 DAYS LATER AND IT WAS ¿WORKING.¿ THERE WAS NO MOTOR STALL OR ALARM NOTED IN THE EVENT LOGS. THE PATIENT WAS FEELING PAIN RELIEF. THE PUMP WAS USED TO DELIVER MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297482 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00048 YR |