FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1943653
·
Received December 21, 2010
Report
- Report Number
- 3004209178-2010-10633
- Event Type
- Injury
- Date Received
- December 21, 2010
- Report Date
- December 9, 2010
- 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT RECEIVED "VERY GOOD RELIEF" DURING THE TRIAL PHASE; HOWEVER, SINCE THE PUMP WAS IMPLANTED, SHE HAS NOT RECEIVED PAIN RELIEF. A CATHETER REVISION WAS PERFORMED IN (B)(6) 2009 DUE TO DISLODGEMENT. PATIENT'S OUTCOME FOLLOWING THE REVISION SURGERY WAS NOT REPORTED. IN (B)(6) 2010, THE PUMP MEDICATION WAS CHANGED FROM MORPHINE TO DILAUDID. PER THE REPORTER, THERE HAVE NOT BEEN VOLUME DISCREPANCIES AT PUMP REFILLS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | CATHETER: MODEL 8731SC, LOT #: N152795001| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8598A, LOT #, N196971017| EXPLANTED: |