FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2942434
·
Received February 4, 2013
Report
- Report Number
- 3004209178-2013-01273
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- December 16, 2012
- Report Date
- January 18, 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 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HEARD HER PUMP ALARMING. ON THE DAY OF THE REPORT, THE PUMP WAS INTERROGATED AND IT WAS FOUND THAT THE PUMP WENT INTO SAFE STATE ON (B)(6) 2012. NORMAL UPDATES OCCURRED IN (B)(6). THE PATIENT EXPERIENCED RETURN OF PAIN. FOUR DAYS LATER, IT WAS REPORTED THAT THE ISSUE RESOLVED. NO BATTERY RESET MESSAGE OCCURRED. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND BEING FOLLOWED BY HER PRIMARY DOCTOR. THE CAUSE OF THE EVENT WAS UNKNOWN; NO ELECTROMAGNETIC INTERFERENCE WAS INVOLVED. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID (HYDROMORPHONE) AT 30MG/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47075 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR |