FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3203013
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-04616
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- September 9, 2012
- Report Date
- March 8, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID: 8709, LOT# J0177964R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ¿PUMP IS NOT WORKING RIGHT¿ AND ¿IT IS NOT PROVIDING THE MEDICATION¿. THE PATIENT WAS EXPERIENCING INCREASED PAIN FOR 4 DAYS. IT WAS REPORTED APPROXIMATELY 6 WEEKS LATER THAT TELEMETRY LOGS FROM THE PUMP HAD NOT BEEN READ. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301883 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR |