FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3050588
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05868
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- March 13, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT "WENT INTO PULMONARY EDEMA" ON A TRIP WHERE HE FLEW TO COLORADO. THE PATIENT IS "PRETTY SENSITIVE" TO DOSING CHANGES. THE PATIENT'S SYMPTOMS INCLUDED "WAS PRETTY HAPPY" AND "FELT LIKE IT WAS A BIT TOO MUCH". THE PUMP WAS INFUSING FENTANYL, BACLOFEN, AND CLONIDINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152971 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |