FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1840068
·
Received September 15, 2010
Report
- Report Number
- 3004209178-2010-07006
- Event Type
- Malfunction
- Date Received
- September 15, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 30, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE ACTUAL RESIDUAL PUMP VOLUME WAS GREATER THAN THE EXPECTED VOLUME; SPECIFIC VALUES WERE NOT PROVIDED. THE PUMP WAS "ALMOST FULL". IT WAS NOTED THAT THE PATIENT HAD BEEN GOING IN EVERY FEW WEEKS FOR INCREASES AND WAS UP TO 8MG/DAY; THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. FOLLOW-UP WITH THE PATIENT'S PHYSICIAN WAS RECOMMENDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 48 YR | IMPLANTED:| EXPLANTED:| CATHETER: MODEL #8709SC, LOT #N248463004 |