FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1853888
·
Received September 7, 2010
Report
- Report Number
- 3004209178-2010-06843
- Event Type
- Malfunction
- Date Received
- September 7, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 13, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S HEALTH CARE PROVIDER (HCP) WAS ABLE TO ASPIRATE THE PT'S PUMP RESERVOIR, BUT WAS UNABLE TO FILL THE PUMP RESERVOIR. THE HCP REPORTED THAT THE SILICONE RUBBER SEPTUM WAS FELT WHEN INSERTING THE NEEDLE INTO THE PUMP RESERVOIR. THERE WAS NO INFO PROVIDED REGARDING THE TYPE, CONCENTRATION OR DOSAGE OF MEDICATION USED IN THE PT'S PUMP. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | IMPLANTED:| CATHETER: MODEL 8711, LOT # N195776001| EXPLANTED: |