FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1884889
·
Received October 20, 2010
Report
- Report Number
- 3004209178-2010-08143
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 22, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS AN INCREASE IN BASELINE PAIN. THIS WAS FOLLOWING A REFILL SESSION. THE LOCATION OF THE SYMPTOMS WAS OVER THE PUMP LOCATION. A VOLUME DISCREPANCY WAS REPORTED WITH THE PUMP. THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. PT DID NOT PROVIDE SPECIFIC VALUES FOR VOLUMES. PT STATED THEY WERE EXPECTING "1.1 MG" BUT WITHDREW "5 MG". ADD'L INFO 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 | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N076159013 |