FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1993783
·
Received January 13, 2011
Report
- Report Number
- 3004209178-2011-00347
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Report Date
- January 10, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A SMALL AMOUNT OF INCREASED PAIN FOLLOWING RADIATION THERAPY. THE PATIENT FELT THAT THE DEVICE WAS NOT WORKING PROPERLY AND WANTED THE PUMP "CHECKED OUT". THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CATHETER: MODEL 8709SC, LOT# N255325002| IMPLANTED:| EXPLANTED: |