FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3051422
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05950
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- March 14, 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
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD RUN OUT OF MEDICATION AND WENT INTO SEVERE WITHDRAWALS APPROXIMATELY TWO YEARS PRIOR TO REPORT. IT WAS STATED THAT THE EVENT OCCURRED AS THE MANAGING PHYSICIAN WAS ON VACATION DUE TO A HOLIDAY WHEN THE PATIENT HAD NEEDED A REFILL. THE PATIENT WAS CHECKED INTO A HOSPITAL AND PUT ON 'SOME MEDICINE' UNTIL THE PHYSICIAN CAME IN ON THE FOLLOWING MONDAY FOR THE REFILL. THE DEVICE SYSTEM WAS INFUSING MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153499 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |