FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202369
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-00103
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- March 28, 2012
- Report Date
- March 28, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE REFILLING A PATIENT¿S PUMP TELEMETRY DID NOT COMPLETE AND THE PUMP WAS PUT INTO STOPPED PUMP MODE. IT WAS NOTED THAT IN THE MIDST OF REPROGRAMMING AN ERROR MESSAGE APPEARED ON THE PROGRAMMER. IT WAS THOUGHT THAT THE PROGRAMMER WASN¿T ¿RIGHT OVER THE ANTENNAE.¿ THE PHYSICIAN REPROGRAMMED THE PUMP OUT OF STOPPED PUMP MODE. THE DRUG IN THE PUMP WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302981 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00010 YR |