FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3234056
·
Received July 18, 2013
Report
- Report Number
- 3004209178-2013-11975
- Event Type
- Injury
- Date Received
- July 18, 2013
- Report Date
- June 25, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8711, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AND ALMOST DIED. THE PATIENT WAS SEEKING A PHYSICIAN TO MANAGE HER CARE. THE PUMP WAS DELIVERING FENTANYL.
Description of Event or Problem · 1
IT WAS LATER REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THE DEVICE OR THERAPY BUT WAS WORKING WITH THE DOCTOR OR MANUFACTURER REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT DATE OF (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335125 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |